chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a little bit of chills; This is a spontaneous report received from contactable consumer. The reporter is the patient.  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 04Feb2021 (Lot number: EH9809) at the age of 80 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COPD", start date: 2005 (unspecified if ongoing), notes: diagnosed 20 years prior (as reported); "sleep difficulty" (unspecified if ongoing), notes: alprazolam helps her sleep; "smoker for a long time" (unspecified if ongoing), notes: quit about 20 years prior. Concomitant medications included: ANORO taken for chronic obstructive pulmonary disease, start date: 02Feb2021 (ongoing); ALBUTEROL [SALBUTAMOL] taken for chronic obstructive pulmonary disease (ongoing); ALPRAZOLAM EXTENDED RELEASE taken for insomnia, start date: 2005 (ongoing); ATORVASTATIN. Vaccination history included: Flu shot, administration date: Oct2020, for immunisation, reactions: "chills", "didn't feel good", "low grade fever"; Old shingles shot, administration date: Oct2020, for immunisation, reactions: "chills", "didn't feel good", "low grade fever". The following information was reported: CHILLS (non-serious) with onset 05Feb2021, outcome "recovered" (05Feb2021), described as "had a little bit of chills".  Additional information: The chills lasted for 5 minutes. The lot number was reported as EH9809, but it was also stated that it could be EM or EN, and the vaccine was administered at 2:15 pm or 2:30 pm. The events did not result to emergency room or physician office visit. The patient did not have prior vaccinations within four weeks. The patient stated she stopped taking umeclidinium bromide, vilanterol trifenatate (ANORO) on 10Feb2021 due to heartburn, and started using again on 19Mar2021; said she might stop using it again. She also stated her temperature was higher than normal when not taking the umeclidinium bromide, vilanterol trifenatate.  No follow-up attempts are possible. No further information is expected.
Post injection day 8 - red, itchy, raised, hive like bump at the injection site.  Improving on day 9, however red bump still present.   Headache also day 9.
Patient received FLUMIST on Friday, then had 2 days of fever, fatigue, muscle aches. Patient reports headache during the fever. Mom took to urgent doc and dx with OM, given amoxicillin.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 06-MAR-2013 at 10:20 am, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 50.50 hours (also reported 17 hours -1, then 130, 2 admin). The patient was not experiencing any known symptoms. This is one of several report from the same source. Additional information has been requested.
Current: Severe pain and swelling in left armpit; feels as if it is cut open. Swelling is visible, and armpit is hard and hot to the touch. Yesterday (resolved): fever of 102, profound chills, skin was painful all over, mild headache and low backache, exhaustion.
got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced COVID-19 (got COVID). At the time of the report, COVID-19 (got COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
low grade fever; lymph nodes swelled; eyes got dryer; Inappropriate age at vaccine administration; This case was reported by a consumer via interactive digital media and described the occurrence of low grade fever in a 36-year-old patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced low grade fever, enlargement of lymph nodes, eye dryness and inappropriate age at vaccine administration. On an unknown date, the outcome of the low grade fever, enlargement of lymph nodes and inappropriate age at vaccine administration were unknown and the outcome of the eye dryness was not recovered/not resolved.   It was unknown if the reporter considered the low grade fever, enlargement of lymph nodes and eye dryness to be related to Meningococcal B vaccine.  Additional details were provided as follows: At the age of 36 the patient went to the school to receive a dose of Meningococcal B vaccine, which led to an incorrect age at vaccine administration. The patient was misinformed and was told that the patient had to have it. The patient developed very low grade fever and every single one of lymph nodes were swelled and also noticed shortly after this that eyes got dryer and still to this day, the patient suffer with dry eyes and can no longer wear contacts. The patient inquired, how to remove the effects of this vaccine out of the patient's body.
My left arm between my elbow and shoulder aches like a muscle ache but I haven't done anything to strain muscle.  I spoke with the pharmacist and with a medical doctor and they have not heard of a reaction as such from this vaccine.  I have no idea what caused it so checking.  It started just where the injections was given and has spread to that entire area.  The swelling a rash are gone but now have this soreness.
Patient experienced a welt at the site of injection.  He then developed a rash down his arm.
Patient passed out about 60 seconds after receiving the flu shot. Covid shot had been given about 15 mins prior to flu shot. Patient was sitting in a chair and slumped over onto the floor. Was checked by EMTs and refused to be taken to hospital, signed medical release forms to not go. Was unconscious for less than 60 seconds. Could hold a conversation immediately after passing out, stated that she could see me and that she felt ok other than a little nauseous and dizzy. Patient stayed on floor until EMT arrival about 5 mins later. Vitals were good other than slightly high HR
Within one minute of receiving vaccine, patient fainted. Patient was unresponsive for a few moments and then did resume consciousness. Patient reported that he did vomit later in the evening once he was at home. Patient also reported that he experiences syncope with every procedure he has ever had that involves a needle.
several hr p/vax pt devel a pruritic rash in both axillae, groin area, & under stomach & breast folds;rash was described as a mass of red w/a few white pimples;pt self-treated w/hydroxyzine & seldane;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 31Dec2022 to 05Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the reported events Drug ineffective and COVID-19 cannot be excluded for the suspect product  BNT162b2, BNT162b2 omi ba.4-5.
I had been very unfocused and could not concentrate at work. I then developed a scratchy throat I then took at COVID-19 Home test while I was at work and that was negative. I took a second one when I got home and it was positive. I was having fatigue, nausea, headache, sore throat, it was hard to breath, I was coughing and just really not doing well. I reached out to my doctor and they gave me Paxlovid to help with my symptoms. By the 26th I was doing better. I took another test and it was negative on the 28th. I was feeling poorly again and was positive again on the 30th. This time I was having the same symptoms but it was not as severe. Since having COVID my symptoms with my heart condition have flared up and when I went to the ER for that they did ask if I had had a COVID vaccine recently.
The day after the shot I had numbness in my right leg and foot. Three days after the shot I woke up with the inability to taste. I can smell but no taste.  ?Pfizer-BioNTech COVID-19  Vaccine EUA?
This spontaneous report as received from a pharmacist refers to two unspecified patients of unknown age and gender. There was no concurrent conditions, medical history and concomitant medications reported. On an unknown date, the two patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, route of administration, lot#, expiration date were not reported). No adverse events were reported. Additional information has been requested.
Raised dry lumps on scalp after second shot; Itchy scalp constantly after second shot; Pain in scalp constantly after second shot; Rash spots on the scalp spread more after second shot; Fever >101.2F after second shot; Chills after second shot; Aches entire body after second shot; Very ill after second shot; Migraine headache after second shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very ill after second shot), MIGRAINE (Migraine headache after second shot), SKIN IRRITATION (Raised dry lumps on scalp after second shot), PRURITUS (Itchy scalp constantly after second shot) and PAIN OF SKIN (Pain in scalp constantly after second shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Sep-2021, the patient experienced ILLNESS (Very ill after second shot), MIGRAINE (Migraine headache after second shot), PYREXIA (Fever >101.2F after second shot) and CHILLS (Chills after second shot). 07-Sep-2021, the patient experienced MYALGIA (Aches entire body after second shot). On 08-Sep-2021, the patient experienced SKIN IRRITATION (Raised dry lumps on scalp after second shot), PRURITUS (Itchy scalp constantly after second shot), PAIN OF SKIN (Pain in scalp constantly after second shot) and RASH (Rash spots on the scalp spread more after second shot). On 09-Sep-2021, ILLNESS (Very ill after second shot), PYREXIA (Fever >101.2F after second shot), CHILLS (Chills after second shot) and MYALGIA (Aches entire body after second shot) had resolved. On 14-Sep-2021, MIGRAINE (Migraine headache after second shot) had resolved. At the time of the report, SKIN IRRITATION (Raised dry lumps on scalp after second shot), PRURITUS (Itchy scalp constantly after second shot) and RASH (Rash spots on the scalp spread more after second shot) outcome was unknown and PAIN OF SKIN (Pain in scalp constantly after second shot) had resolved.             No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-326169 (Patient Link).
Vaccine given to minor, 17 year old although guidelines state 18 years and older for Janssen vaccine. Patient and mother notified of error. No adverse reactions at this time.
Lip and tongue swelling and facial palsy on left side (started 45 minutes after injection). 5-day regimen of Prednisone was prescribed on 4/21/21 Facial palsy continued for 6 weeks, sensation of tongue and lip swelling persists to today. In addition, intermittent sharp pain from left cheek to left ear. Numbness and tingling in extremities, which started within 15 minutes of injection, persist to today. Fatigue, which set in after initial 5-day regimen of Predisone, persists to today.  A 30-day regimen of Prednisone was prescribed on 07/23/21.
Local reaction where vaccine was administered in the left SQ area of the posterior arm. Redness, swelling and heat - increasing in size.
Hives and itching 11-12 hours post injection. BENADRYL x 1 dose, 6 hours post BENADRYL rash and itching, BENADRYL repeated.
Severe headache commencing about 4 hrs after shot. Worsened & tightness in chest occured at about 6 hours. Wheezing resulted. Condition resolved itself after several hours without intervention.
This spontaneous report as received from a nurse refers to an unspecified number of patients unknown age and gender. Nurse reported that the temperature on the freezer/refrigerator unit was not recorder between the dates of 29-APR-2013 to 28-MAY-2013 (reported as 28-MAY-2012). The vaccines involved were: Refrigerated vaccines: M-M-R II, RECOMBIVAX HB, VAQTA, ROTATEQ and PNEUMOVAX23. Freezer vaccines: (Oka/Merck) VARIVAX and ZOSTAVAX. Concomitant medications were not reported. It was not known whether the vaccines stored in the unit underwent any type of temperature excursion, or any doses of the vaccines were administered. Additional information has been requested.
vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a male 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 reaction (No medical history).    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 VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.    Reporter did not allow further contact
reported by patient stated that after 24 hour after receiving the J&J vaccine she " couldn't lift her head, fever, chills,  headache that comes and goes, body aches, leg cramps,
The patient reports local swelling/inflammation in same arm as was injected. No complaints of redness or pain. Swelling began either day of injection (following vaccine administration) or day after and has not gone down now 10 days later. Patient has never experienced an adverse reaction when given an immunization.
Pt received her covid vaccine,  pt did not wait, was walking around withfather, she felt dizzy and dad reported she fell. we did not see her fall. She was sitting on 20 when dad came toget us. Pt felt dizzy, ringing in ear, had her lay down on floor with feet elevated. BP pressure reading were 128/75 hr 70, 130/72, 75, pt now feeling better  and sitting 108/76 64 108/76 64 and 118/76 76. Pt father declined ems.  Pt waited until she felt normal, drank bottle of water, no longer dizzy, went home. Father instructed on emergency care. Followed up call with father at 5:08pm. Fahter reported she was tired, sometimes sob and advised to take pt to e.r. for evaluation.
ADVERSE EVENT 19JUN18: VACCINE ADMINISTERED AT 1020. ONSET OF RASH ON RIGHT ARM AT 1700, RASH SPREAD TOWARDS FACE AND INCREASED ERYTHEMA SINCE ONSET. TREATMENT 20JUN18: PREDNISOLONE 15MG/ML AND BENADRYL ORAL SUSP. 12.5MG/5ML OUTCOME: TBD.
cold like symptoms; sore throat; constantly blowing her nose; her head is so stopped up; trouble breathing, like catching her breath; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine) via unspecified route of administration in arm left on 03Apr2021 (Lot EP7533, unknown expiration date) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as no. The patient experienced trouble breathing from 05Apr2021, cold symptoms from 07Apr2021. On 05Apr2021, the patient started having trouble breathing, like catching her breath. On 07Apr2021, the patient came down with like a cold. She felt cold like symptoms, a sore throat. She was constantly blowing her nose, her head was so stopped up, the symptoms came on all of the sudden, she felt very unlucky. The patient would like to know whether their side effects; problems breathing, trying to catch her breath, cold-like symptoms and a sore throat, were related to the COVID vaccine. The patient also asked if please get COVID from the covid vaccine, if she had COVID, what should the patient need to do. Investigation assessment was reported as no. Her second dose is scheduled on 24Apr2021. The outcome of the events was not resolved.   No follow-up attempts are needed. No further information is expected.
The patient was administered the Pfizer bivalent as the second dose in the primary series.  No adverse reaction reported.
No adverse event; Dose 1: 01 Mar 2021, Dose 2: 6 Apr 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01 Mar 2021, Dose 2: 6 Apr 2021) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Adverse drug reaction (Arava reaction) in 2015 and Spinal stenosis (left L4-5 Spinal stenosis secondary to L4-5 facet cyst) on 08-May-2018. Concurrent medical conditions included Rheumatoid arthritis since 2005, Hypertension, Psoriasis, Depression since 2015 and Osteoporosis. Concomitant products included ABATACEPT (ORENCIA) from September 2015 to an unknown date for Rheumatoid arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01 Mar 2021, Dose 2: 6 Apr 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01 Mar 2021, Dose 2: 6 Apr 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant products included intravenous bisphosphonate from Jul-2016 to an unknown date for osteoporosis.  Reported that patient received METHOTREXATE orally from December 2021 to an unknown date for Rheumatoid arthritis.  The patient had received an unspecified Pfizer product in Jun-21 and was stopped in Jan-22, 2000 mg which was used for an unknown indication. An unspecified Pfizer product was stopped due to inadequate initial response.  No treatment drug details was reported.
Patient developed fatigue and fever after a few hours. The next day she chills, body aches, headache, continued fever. Took Tylenol to treat. Arm is sore and she is unable to use it; swollen but no rash.
Menstrual period came early and much heavier than normal. Very intense menstrual cramping. Period lasted longer than normal. Very painful ovulation and constant bloating. Menstrual period has been light, short and easy for 15 years and up until receiving the COVID-19 vaccine.
Information has been received from a healthcare worker (office manager) via a field representative concerning a 15 year old male patient. The patient's medical history and concurrent condition were not provided. On 11-MAY-2015, the patient was vaccinated with his first dose of GARDASIL 9, intramuscularly as vaccination (lot#, expiration date and dose not provided). Concomitant therapy was not provided. On 11-MAY-2015, after receipt of GARDASIL 9, the patient "fainted, hit his head" and when he "came to, he vomited". The patient was treated "conservatively" in the office then sent home. Therapy with GARDASIL 9 was also reported as continued. The outcome of the events was unknown. Additional information has been requested.
2-26-08 EE rcv'd the Hep B vaccine yesterday ~2p.  EE seen in Health Services ~ 12:40p.  States he has a h/a, is dizzy, feels 'lousy' over the past 4 hours.  Feels like he's getting worse.  States he felt fine prior to that.  Many ee's have been sick w/flu, etc.  BP 120/86, P-88/reg. T-97.5.
Full body rash, understood to be typical within 7 to 12 days of receiving the MMR.
A report was received form a health care professional on 11/17/03 concerning a 27 year old female vaccinee who experienced mild itchy rash 6 hours after receiving Fluvirin on 11/10/03. On 11/10/03, the vaccinee experienced a mild itchy rash that started on the arms and progressed to the chest and back. Diphenhydramine hydrochloride and loratadine were prescribed for symptomatic relief. The vaccinee had not recovered at the time of the report. The vaccinee had no prior history of allergies and had received Influenza vaccine on an unspecified date in 2002. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Left arm swelling, pain, itchy, hot, and redness. Body aches and temperature.
EXPIRED IMMUNIZATION GIVEN (PREVNAR 13 EXP 01/30/2013).  IRIS/CDC NOTIFIED. PATIENTS MOTHER NOTIFIED. NO ADVERSE REACTION NOTED, PATIENTS MOTHER INFORMED THAT IMMUNIZATION NEEDS TO BE REPEATED. IMMUNIZATION MAY BE GIVEN IMMEDIATELY.
Sudden severe itching at around injection site, redness, some swelling/hardness one week after injection. At time of injection I had no abnormal reactions-- just pain around the injection site for a couple days and I was a bit tired. Used a Cortisone cream and tec-nu itch and pain relieving gel (Diphenhydramine HCL 2%, Zinc acetate 0.215%) which decreased the itching substantially with no effect on redness or swelling. Almost 24 hours later, persistent mild itchiness, red patch is same size (approx 2"x3" oval-ish shape), and still feels like there is some swelling/hardness. I haven't spoken with a medical professional about this yet.
Patient reported mild symptoms (dizziness) that resolved approximately 15 minutes after receipt of first dose of COVID vaccine reported fatigue in the days after receipt of the vaccination
urticarial rash over most of body, treated w/pred on 1JUN95-1DEC95