chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This literature marketed report as received from a health care professional refers to a 4.7 year old patient. Effectiveness of varicella vaccine (manufacturer unknown) was assessed by reviewing the medical records of closely monitored HIV-infected children, including those receiving highly active antiretroviral therapy (HAART) between 1998 and 2007. The medical records of 164 perinatally HIV-infected children from between 1989 and 2007 were reviewed to determine whether and when they had received varicella vaccine (manufacturer unknown), developed varicella, and/or developed herpes zoster. All perinatally HIV-infected children were included except for those who developed varicella before 1 year of age because varicella vaccine (manufacturer unknown) was not given before then. Immunized children received at least 1 dose of live attenuated varicella vaccine. The effectiveness of the vaccine was calculated as 1 minus the rate ratio. Incidence rates of varicella were calculated for 2 periods: the prevaccine era for HIV-infected children (1989-1998, when none of the children received varicella vaccine) and the vaccine era (1999-2007). Rate ratios for development of herpes zoster among children who had been immunized versus those who had varicella were calculated. It was reported that patient developed breakthrough varicella at 4.7 years after the last immunization. The outcome of the event reported was unknown. The author considered the event as related to varicella vaccine (manufacturer unknown). This case is linked to the case 1405USA004682 via Same Literature Link. Additional information has been requested.
Patient received a Tdap vaccine yesterday.  She reports that last night (9/30/2010 at 10 p.m. she had unexplained chills.  She did have 1 episode of vomiting.  She felt some feeling of needing to take some deep breaths. Eventually, she was able to fall asleep at midnight and was able to sleep. Today she still has body aches.  She has a backache.  She has discomfort even in her ankles and toes.  She reports she felt some chills earlier this morning, but not since then. She currently denies cough, sore throat, nasal discharge, ear pain, headache or dysuria.  She has had no recent travel.  She does admit that she has not been drinking many fluids today.
Patient felt light headed x 1 hour.  drank H2O and laid down and resolved.  Declined ED evaluation. All vitals within normal limits.    #21. d/c home with instructions to return if new symptoms or old recurred.
Information has been received from a physician concerning his wife who was in her late 30s who on approximately 02/03/2006 was vaccinated with a 0.5ml dose of MMR and varicella live vaccine.  The physician reported that on approximately 02/03/2006, his wife developed swelling around the injection site.  Unspecified medical attention was sought.  In February 2006, the patients injection site swelling resolved without treatment and she was noted to be fully recovered.  Additional information has been requested.
vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No medical history were reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) 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.   No concomitant information was reported. No treatment information was provided.   This case was linked to MOD-2021-163966 (Patient Link).
This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, drug history, and concomitant medications were unknown. On an unknown date the patient was vaccinated with PROQUAD lot # M007961 (exp 15-AUG-2017), subcutaneous in back of arm. The patient received the vaccination which had undergone a temperature excursion. The patient did not experience an adverse event. It was unknown if there was any relevant laboratory data. As of 06-OCT-2016 it was unknown if the patient was continued with PROQUAD. The outcome of patient received vaccination that underwent temperature excursion was unknown. This is one of several reports received from the same source. Additional information has been requested.
turned blue in color, raspy irregular shallow breathing shaking (poss sz); t104 in ER;
This spontaneous report as received from a healthcare refers to an unspecified amount of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, an unspecified amount of patients were vaccinated with doses of GARDASIL (lot number, dose and route were not reported) that underwent a temperature excursion. Concomitant therapies were not reported. No adverse effect was reported. Follow up has been received from a registered nurse, who provided the lot numbers for the GARDASIL that experienced temperature excursion. The following lot numbers were reported: lot number reported as J0105378 (expiration date 09-APR-2016) (captured in this report) and lot number J006850 (expiration date 31-MAR-2016) (captured in MARRS# 1406USA011141). Lot number J0105378 is an invalid lot number for GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
After 2nd shot, I was very sleepy. After 3rd shot (11/16/2021), I got a rash from injection site on left upper arm down to almost the elbow on the front side of arm. I am doing better now but quite itchy. I used witch-hazel to help stop itching. It is not as red today (day 4).
There was no adverse event with vaccination Look A Like Pfizer bottle resulted to give Pfizer Biontech Covid 19 instead of Pfizer Bivalent  Patient was ok Offered to give him Bivalent booster in 2 months
IZ given on Friday, Feb 7th. Wife reports she had to help pt. up from bed next day, Feb 8th as husband was very weak. That evening he had fallen in the bathroom and could not get up. Ambulance was called. Pt was discharged the same night, then wife reports he got better daily. ER diagnosis was anemia, fall at home, and weakness. Pt. did see his provider the following week. Provider stated pt was no longer anemic and muscle test was normal. Also HCP tended to agree with pt., that he had a reaction to the shingles vaccine. Pt refused second shingles vaccine and this was when I learned about the incident.
TWO WEEKS AFTER HAD A BALL ON THE CHEST NEXT TO HEART WHICH HURTS; This spontaneous report received from a consumer concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, non alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and there was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 20-JAN-2022) dose was not reported, administered on 08-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 57 years old. Concomitant medications included metformin for diabetic, acetylsalicylic acid for drug used for unknown indication, and atorvastatin for drug used for unknown indication.  On MAR-2021, the patient experienced two weeks after had a ball on the chest next to heart which hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two weeks after had a ball on the chest next to heart which hurts. This report was non-serious.
On 1/11/21, the next day the arm was swollen, hot, bruised, and so swollen that she had to use an XL shirt, wears M.  Had red splotches on it, pain and swelling for 7 days after the vaccine.  There was red splotches on the arm, but now 2/15/21 there are now white dots where the red lines used to be.   Did not take anything for it, as she did not know what to do.  She called her doctor, but they did not address the problem.  When she went to work on 1/12/21 had another lady that is a corporate nurse and told her that it was bad.   Arm is still hurting, and is in the process of recovering.   If she pushes on the location of the vaccine it does hurt.  She has not and will not take the 2nd vaccine.
Generalized macular lesion on the site vaccine was given. Dermatitis-hydrocortisone 1% apply BID, return in 2 days for follow up.
Patient was admitted with recurrent TTP. The pt has several week of fogginess. She has low grade fevers, diarrhea and malaise as well. However she has also had a Covid vaccine at the beginning of symptoms (4/13/21 Moderna, which was not recorded in computer). Most of her symptoms have abated except for the fogginess which led her to the ER. Platelet count 16 on admission. Hemoglobin has dropped from 12.3 January this year down to 10.5.
Felt dizzy; Headache when I bends over/bad headache; lymph node of neck on left side was swollen; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy), LYMPHADENOPATHY (lymph node of neck on left side was swollen) and HEADACHE (Headache when I bends over/bad headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included Parathyroid gland operation (mentioned doctor took out her parathyroid gland 5 years back) in 2016. Concurrent medical conditions included Drug allergy (Statin:HMG-CoA reductase inhibitors), Allergic reaction to analgesics (Ibuprofen), Drug allergy (Synthroid), Allergic reaction to antibiotics (Doxycycline), High cholesterol (genetic as per the endocrinologist) since 1985 and Drug allergy. Concomitant products included FISH OIL for High cholesterol, CALCIUM, TURMERIC [CURCUMA LONGA RHIZOME] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 28-Apr-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021 at 8:00 AM, the patient experienced LYMPHADENOPATHY (lymph node of neck on left side was swollen). On an unknown date, the patient experienced DIZZINESS (Felt dizzy) and HEADACHE (Headache when I bends over/bad headache). On 09-May-2021, LYMPHADENOPATHY (lymph node of neck on left side was swollen) had resolved. At the time of the report, DIZZINESS (Felt dizzy) and HEADACHE (Headache when I bends over/bad headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Heart rate: low (Low) Low heart rate. On 10-May-2021, Blood pressure measurement: 119/71 Low. On 10-May-2021, Heart rate: 44 Low. On 12-May-2021, Blood pressure measurement: 120/77 (Low) after running errands she monitored it again and it was 124/73, pulse rate 55.. On 12-May-2021, Heart rate: 44 (Low) after running errands she monitored it again and it was 124/73, pulse rate 55..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported   This case was linked to MOD-2021-221135 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated patient demographics[Height, Weight, Race], Updated Medical History: allergy[HMG-CoA reductase inhibitors], current condition: high cholesterol.  Updated outcome of event Swollen lymph node on left side from Unknown to recovered. On 06-Aug-2021: Follow up received and it contains no new information.
1 day p/vax pt reported swollen glands, sore throat, pain w/talking, swallowing lasted 1wk-sx reported to MD 13JAN97;no fever, no adenopathy;
Child received DTaP #4 and Prevnar on 09/17/03. Return to clinic 9/19/03 due to diffuse redness and swelling to anterior right thigh. No cellulitis. Dx as local reaction to vaccine.
w/in 1 min of DTP, reddened blotchy area, about 1/2-1cm ea, rt deltoid; about 8 areas w/some coalesced; lt deltoid (HIB site) devel 3-4 similar reddened blotches-not as bright; blotchy area began fading w/in 10 min; DPT site sl edema;
over 42 days. pt got infected with covid after 1st dose, waited for 3 months. 1st dose 07/9/21 2nd dose 10/11/21
SOB upon exertion, fatigue, headaches, severe pain all over- Long standing SE- High Blood pressure, cardiac inflammation & cardiac stent, SOB
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. In an unspecified date in 2006, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, also reported as (2 months after the first dose), the patient received the second dose of GARDASIL 9. On an unknown date, also reported as (2 weeks early), the patient was administered the third dose of GARDASIL 9 (inappropriate schedule of product administration). The outcome of the event inappropriate schedule of product administration was not reported.
BOTH ARMPITS LOOK VERY BRUISED AND THE ARM WHERE HE GOT THE SHOT IS MORE BRUISED LOOKING THAN THE OTHER AND BOTH ARE TENDER TO THE TOUCH.
had "COVID arm; delayed cutaneous hypersensitivity; It presented as a reddish area of skin, slightly raised, roughly 4-x-7-inches.; Not as itchy as some describe, but definitely a rash-like appearance with the oval shape; I experienced only mild discomfort in the affected the area.; It felt warm to the touch; sensitive but in a sore way,; This is a spontaneous report from a contactable Consumer or other non HCP (patient). A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9263), via an unspecified route of administration on Left arm on 04Feb2021 02:30 PM (age at vaccination: 67 years) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as Other. The patient medical history included Glaucoma and Hair loss and had no known allergies. Device Date was reported as 26Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient Concomitant medications within 2 weeks of vaccination included bimatoprost (LUMIGAN) taken for Glaucoma from an unknown date and Finasteride (PROSCAR) taken for Hair loss from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3246), via an unspecified route of administration on Left arm on 13Jan2021 02:30 PM (at the age of 67 years) as dose1, single for COVID-19 immunization. On 07Feb2021 12:00 PM, In reaction to my 2nd dose, I had "COVID arm" or delayed cutaneous hypersensitivity. This appeared 3 to 4 days after the 2nd dose was administered. It lasted for 4 to 5 days. It presented as a reddish area of skin, slightly raised, roughly 4x7 inches. Not as itchy as some describe, but definitely a rash-like appearance with the oval shape.  I experienced only mild discomfort in the affected the area. It felt warm to the touch, sensitive but in a sore way, as if the inoculation site soreness was simply wider and more diffused than usual. My concern was that this might have been a subcutaneous injection rather than injection into the muscle. I now realize "COVID arm" is what this was. It's a relief because I believe now that I've got the full protection of the second dose. Since the vaccination, the patient has been tested for COVID-19. The lab tests included test: SARS-CoV-2 test (nasal swab), result: Negative((#) COVID-19 Combo)on 14Mar2021. Treatment received as a result of events was reported as no. The outcome of Not as itchy as some describe was recovered on 2021, while the outcome of the other events was recovered on Feb2021.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
full body itching onset approximately 6 or 7 pm, lasting until after I took Benedryl and fell asleep around midnight. Felt weak with weak pulse.
This spontaneous report was received from a medical assistant and refers to unspecified patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L037554, expiration date 25-DEC-2017 (dosage and route of administration were not reported) for prophylaxis, which were exposed to temperature excursion of -1°C or colder for a time frame of 15 minutes because of data logger. There was no previous temperature excursion. No adverse effects were reported.; Sender's Comments:  US-009507513-1709USA010108:
Lightheaded, burning pain radiating from neck up into head. Throat became swollen, did not close but felt like breathing through a straw when breathing and felt like I was swallowing something, almost choking on swallowing. Extreme fatigue. On day 2 of arm, neck and head pain.
Patient complained of chills, throat itching and discomfort at 10:11 am, able to speak normally. Vital signs initiated, covered with sweater, advised deep breathing as patient was anxious. At 10:25 am Noted mild swelling on left lateral tongue with normal vital signs. Benadryl intramuscular administered, dose confirmed by two register nurses and the head leads.   checked vital signs within normal limits, patient stated feeling better, symptoms swelling and itchiness resolved. 11:20 am Patients stated feeling better, vital within normal limit, verbalized no more throat or tongue discomfort. Discharged with company of a friend to home. Advised to go to ER in case symptoms come back or breathing difficulties.
Pt came in with complaints of a bruise on the left thigh where the DTaP was given. Parents stated Saturday on 03/09/2002 was when the bruising started. They took the pt in that same day to the ER. We saw him here today on 03/11/2002 for the bruising around 12:45pm.
Blistering/vesicular rash on (R) anterior wrist and posterior 3rd-5th digits. Rash also noted on (R) upper thigh.
PT RECEIVED VACCINE AT DAY 22 INSTEAD OF DAY 28. PT REPORTS ONLY FATIGUE
Swelling of right cheek.  Worse in mornings.  No treatment - just monitored.
5/25/2021, Patient was observed post Covid-19 immunization for 15 minutes. During the observation period, she experienced an adverse reaction with the following symptoms: "woozy" feels that blood sugar is low. Assessment; Time of assessment 1555. Alert and oriented. Actions taken: Vitals sign taken. VAERS form obtained and completed by RN.  1555 ; 118/72, P- 64, 1610: BP- 112/65, P- 64, O2- 98%. Crackers and juice given. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered, Name; Patient, Date, Dose, VIS Date, Route, Pfizer COVID-19 Vaccine, 5/25/2021  3:47 PM, 0.3 mL, 2/25/2020 Intramuscular, Manufacturer: Pfizer, Inc, Lot: EW0164, NDC: 59267-1000-2
covid arm; headache; hypothyroidism became hyperthyroidism; heart palpitations; vertigo; extreme mucus; unable to sleep; A spontaneous report was received from a consumer (patient) which concerns a 73-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  vertigo, headache, extreme mucus, heart palpitations, unable to sleep, turned hypothyroidism to hyperthyroidism and covid arm.   The patient's medical history was not provided. Concomitant medications included amlodipine, diphenhydramine hydrochloride, diazepam, thyroid and vitamins (ascorbic acid; ergocalciferol; nicotinamide; retinol; riboflavin; thiamine hydrochloride).  On 10-Feb-2021, the patient received first dose of mRNA-1273 (Lot number: 010M20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 10-Feb-2021, the night of shot the patient experienced vertigo, headache and extreme mucus that lasted 3 days. The same day as the shot she also experienced heart palpitations, unable to sleep, turned hypothyroidism to hyperthyroidism and these symptoms lasted 8 days. On 22-Feb-2021 she experienced covid arm that got better but was still present.   Treatment medications included tylenol.  Seriousness criteria for the event of hypothyroidism became hyperthyroidism was medically significant.  Action taken with mRNA-1273 was unknown.  The outcome of the event of covid arm was recovering and for all other events was recovered.  No further information was provided.; Reporter'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.
Approximately 10 hours post vax the pt experienced a systemic rash with itching and burning. An ER or doctor visit was required and unspecified treatment was given. The most recent information received reports the condition of the pt is unknown.
arm was red warm swelling & itchie; pt was told to put cold packs also took APAP & ran a fever;
Injection site is swollen, feverish and red. Pain at time of administration is worsening. No tingling. Not itchy. No probelms other than at injection site.
received a Fluzone Quadrivalent after 2 days of shipping and vaccine was not viable, no adverse event; received a Fluzone Quadrivalent after 2 days of shipping and vaccine was not viable, no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist on 05-Nov-2019.  This case is linked to 2019SA310491 and 2019SA310490.  This case involves a 56 year old female patient who received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ270AA, Expiration date 30-JUN-2020) via intramuscular route in the left deltoid in Nov-2019 after 2 days of shipping, vaccines were nonviable.  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  No other vaccine was given.   It was a case of actual medication error due to product storage error and product distribution issue.  it was reported that patient received a Fluzone Quadrivalent after 2 days of shipping which were not viable.  At the time of report no adverse events were observed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: 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.
Left arm swollen from shoulder down to just below elbow. Area not tender but indurated over triceps area. Also macular erythematous eruption over affected are. (L) arm 3 cm large. Then right in diameter.