chrisvoncsefalvay/vaers-outcomes huggingface dataset:
denied them their second dose due to their reaction to the first dose; lump on her neck; White spots; Hives on her chest; Rash; lips swollen; Tongue swollen; Face swollen; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on her chest ), RASH (Rash), LIP SWELLING (lips swollen), SWOLLEN TONGUE (Tongue swollen) and SWELLING FACE (Face swollen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced URTICARIA (Hives on her chest ), RASH (Rash), LIP SWELLING (lips swollen), SWOLLEN TONGUE (Tongue swollen) and SWELLING FACE (Face swollen). On 07-May-2021, the patient experienced SKIN DISCOLOURATION (White spots). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (denied them their second dose due to their reaction to the first dose) and NECK MASS (lump on her neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 2 doses. At the time of the report, URTICARIA (Hives on her chest ) and NECK MASS (lump on her neck) was resolving and RASH (Rash), LIP SWELLING (lips swollen), SWOLLEN TONGUE (Tongue swollen), SWELLING FACE (Face swollen), SKIN DISCOLOURATION (White spots) and PRODUCT DOSE OMISSION ISSUE (denied them their second dose due to their reaction to the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-138803 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138803:Mother's case
Primary smallpox vaccinee;received SPV on 8/6/03. On Day 10, awoke with chest tightness in center of chest with inhalation; rated pain as level 4/10 on pain scale of 0-10; pain resolved spontaneously after about 15 minutes.  On day 11, noted erythema, mild swelling under tape adhesive. Temp 101.8. Complained of fatigue, and night sweats. Evaluated by doctor on 8/18/04, who noted left axillary lymphadenopathy and 3x3" area of well-defined, erythematous, edematous area at vaccine site; (+) vesicle and numerous small satellite lesions. "Robust take" Placed on quarters x 24 hours. Started Allegra 180mg daily and Motrin 800mg 3x/day.  Called patient on 8/24/04. No recurrence of CP. Fever, fatigue and local reaction  have resolved.
Vaccine below given approximately 1000 AM. Caregiver states child took naps and woke up with rash about 3:45-4:00 PM. Hives, redness, warm to touch right upper arm and right middle thigh noted. Received Tylenol and Benadryl and if symptoms worsen, go to ER.
Information has been received from a physician concerning a 5 yea rold female who in May 1997 was vaccinated in the arm with one dose of varicella virus vaccine live. There were no concurrent medications. It was noted that a rash did not occur at the site of injection post-vacicnation. On 12/13/2001, the child developed a rash consisting of papules and vesicles. There were approximately 50 lesions. There was not recent exposure to chickenpox or shingles. She presented to the physician who diagnosed her with herpes zoster alogn the right L2 dermatome. On 12/13/2001, the physician obtained a specimen from one of the lesions. A Tzanck test showed multinucleated giant cells. The physician prepared a slide from the specimen, which will be submitted for PCR analysis. The pt subsequently recovered. Additional info has been requested.  Follow up information indicated that the interpretation of PCR analysis was "VZV positive, non-typable". Additional follow up information was received on 30OCT2002. The vesicular rash specimen was positive for VZV and PCR analysis of reamplified specimen identified the presence of WT VZV. No further informationn is available.
ACUTE PULMONARY EMBOLISM 5/6/2022 LUNG MASS  HYPOXIA 4/26/2022 LUNG MASS  ACUTE PULMONARY EMBOLISM 5/6/2022 LUNG MASS  HYPOXIA 4/26/2022 LUNG MASS
patient received Hep A #2 too early, as patient is following the vaccination catch up schedule. Hep A #1 was given 7/19/22 Hep A #2 needed to be given 6 months after #1 (1/19/23).
Flu vaccine - not sure what kind.  Paper simply says Influenza Vaccine Inactivated or Recombinant.  Patient was given shot and became increasingly combative and ripped out his IV twice.  He was on a Milrinone drip at the time.  He was first given benadryl in an attempt to allow him to sleep.  His agitation got worse over several more hours.  He was then given 0.5mg of ativan IV push.  He immediately fell asleep.  The next morning it was discovered that he failed to regain full consciousness and was extremely lethargic and difficult to arouse.  It was assumed at the time that this was the result of the ativan not clearing his system.  However, over the course of the day, he remained unconscious for the most part without any signs of improvement.  Suspecting the vaccine was causing encephalitis, he was given 200mg of Ibuprofen at 4:30pm that day.  His condition slowly started improving and he became increasingly easier to arouse.  By the next morning, he was able to open his eyes spontaneously and walk with assistance.
soreness in upper arm; This is a spontaneous report from a contactable consumer reporting for herself.  A female patient of an unspecified age received  bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration from on 06Jan2021 at single dose  for Covid-19 immunisation .  The patient medical history and  concomitant medications were not reported.  The patient experienced soreness in upper arm  on Jan2021 with outcome of unknown.  Information about Lot/Batch number has been requested.
The morning after patient took the first does he started vomiting.  After vomiting all day we took him to Hospital
patient received an expired 0.5ml dose of Menactra in the left deltoid, with no AE; Initial information received on 08-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17-year-old female patient who received an expired 0.5ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6576AB,  expiry date- 04-Apr-2021) in the left deltoid via an unknown route for prophylactic vaccination on 08-Apr-2021 (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported that, the Physician Assistant wanted to know if there is a grace period on the expiration date of a Menactra vaccine given? or do they need to call the patient back to revaccinate?  At the time of report, no adverse event was reported.  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 the 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.
Pt seen in office on 12/15/17 for complaint of bilateral arm soreness and "knots" under skin where injections were given. Pt developed a rash on her left arm under injection site that itches. Dx: Faint erythema.
09/21/22 presents to ED for "chest pain and L sided numbness". PMHx of "hepatic stenosis, dyslipidemia, migraines, PE/DVT on eliquis, MTHFR gene mutation, MGUS, afib s/p ablation"
Within 24 hours, post vax, to left thigh, noted 11cm X 7cm area of inflammation, redness, induration and tenderness. No limp or fever.
In bed high fever nausea arm swollen to elbow extreme soreness.    Slept for 2 days
Patient was given HD Flu instead of Flu vaccine 6+ months quadrivalent 0.5mL (IIV4) preservative free IM fluZONE.  Patient is under the age of 65years. Patient will be contacted & informed by provider and office manager.
life tested positive for HPV; then received GARDASIL 9; This spontaneous report was received from a physician and refers to a female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, expiry date, lot #, expiration date and route of administration were not provided). And then later in life (unspecified date), she tested positive for human papilloma virus (HPV) (Human papilloma virus test positive) so she received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered for prophylaxis (strength, expiry date, and route of administration were not provided) (Interchange of vaccine products). It was unknown how many hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccines she received.   The causal relationship Human papilloma virus test positive and suspect vaccine was not reported.
Prickly heat type rash on right side of neck, shoulder and upper arm with about a dozen red round (not quite dime sized) welts. Itchy when touched. Also a small outbreak at small of back. Was not painful, just itchy. Lasted 4-5 days. I called doctor's office. They asked "Does it hurt?" I said no. They said probably not a problem but we're here if you need us. I did not go in.
I am still feeling a little warm off and on.; I am getting some muscle pain in my lower legs, like a tightness.; Some muscle issues on the side of her calf area, like the inside of her leg area is hurting; I am getting some muscle pain in my lower legs, like a tightness.; I am getting some muscle pain in my lower legs, like a tightness.; This is a spontaneous report received from a contactable consumer (patient) reported for herself that a female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: unknown, expiry date: not provided), via an unknown route of administration on 01Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Apr2021, the patient experienced "I am still feeling a little warm off and on", while she had her shot like two weeks ago. She was not running a fever or anything. She was getting some muscle pain in her lower legs, like a tightness. Some muscle issues on the side of her calf area, like the inside of her leg area was hurting. She gets a little hot too but that was the only two things she has experienced. She wanted to be sure that this was a normal thing. No, this report was not related to a study or programme. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 24 year old female patient with no drug reactions/allergies and no pertinent medical history who on 26-JAN-2012 was vaccinated IM with a dose of GARDASIL (lot # 670049/1171AA, expire on 25-FEB-2013). There was no concomitant medication. On 27-MAR-2012, the patient began to have facial palsy. The physician gave her prednisone for the event. No lab diagnostics studies were performed. The patient came to physician's office to seek medical attention. At the time of reporting, the patient was recovering. Upon internal review, facial palsy was determined to be an other important medical event. Additional information has been requested.
No additional AE/PQC; temperature excursion that was intermittent beginning 28-JUL-2020 / there have been administered doses; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  Since 28-JUL-2020 (conflicting information also reported as 10-AUG-2020), varicella virus vaccine live (Oka/Merck) (VARIVAX) had intermittent temperature excursion, the vaccine was stored at a temperature of -14 degrees Celsius (C) to -10 C (max -9.5C), during a time frame total of 38 hours and 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliter (ml) (lot number S032357 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (it was also reported that the lot number: T002843; expiration date: 23-JAN-2022 was involved, however, information of administration was not provided) (vaccination scheme, frequency, route of administration and anatomical site of injection were not reported), as prophylaxis (product storage error). No additional adverse events were reported in the patient.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014701: US-009507513-2008USA014689: US-009507513-2008USA014749: US-009507513-2008USA014777: US-009507513-2008USA014790: US-009507513-2008USA014797:
Axillary adenopathy L, total size of squashed golf ball, painful.   48 hr of fever then chills, headache, fatigue.  Elevated resting HR and occasional chest ache.  11MAY reported to Dr elevated HR & chest aches. Continuing and spreading adenopathy L., 20MAY short of breath, cough,  chest aches.  Nodes swollen above & below L. clavicle.  22MAY headaches, chest pains sharp 4 times. Bed-rested except 30 min. walk until chest pain then sat until recovered then back to bed. Today total axillary is size of squashed baseball beginning impingement of muscles.
Information has been received from a nurse concerning a 2-month-old patient who on 11-SEP-2006 was vaccinated PO with the first dose of Rotateq. The nurse reported that on 11-SEP-2006, the patient spit up some of the vaccine. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
I had the following symptoms fir approx 2 days: a very sore and swollen arm, temp of 102, bad headache, body aches, fatigue, and bad nausea.
11 days after receiving initial Anthrax (Bioport FAV078) vaccination, pt developed decreased facial nerve activity which resulted in full facial nerve palsy within 24 hours.  Pt admitted to local hospital with negative head CT of Acyclovir treatment 2 grams per day.
I already have aches and pains from a car accident but they were about 5 x worse than usual and even my hands were aching badly along with  nausea and a headache, couldn't sleep at all.  Obviously, today I feel extremely fatigued but the aches and pains have already improved quite a bit (it's now noon, the following day of the vaccination).
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting,  chills, fatigue, swollen glands. Injection site pain with swelling and redness.
Large (10cm x 6cm), firm red swelling on left arm, surrounding vaccination site. Swelling is warm to the touch with intermittent bouts of intense itching. Swelling began around 8PM on the 30th and is still present now (8AM on 1 Feb). Mild discomfort experienced when lifting left arm above head.
Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short duration), slight lymph node enlargement in neck, tiredness, aches and discomfort, "flu-like"  lasted approx. 30 hours
Blood spots/speckles under skin on legs & arms.  Right side of neck near vein/muscle throbbing/ pulsing.  Fatigue, headache.
1 dose that was broken, the syringe; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 30Jan2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: FN5555, Expiration Date: 31Jul2024) for immunisation, Device Lot Number: FN5555, Device Expiration Date: 31Jul2024. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "1 dose that was broken, the syringe".  Additional information: NDC number of Prevnar 13: 0005197101. According to the nurse, the received a Prevnar 13, 1 dose that was broken, the syringe. They received a damaged box, just 1 syringe was damaged in the shipment. When probed if the syringe was used on any patient: Nurse stated, "No".
Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medication was provided.   No treatment  information was provided.   This case was linked to MOD-2021-353224, MOD-2021-353228, MOD-2021-353241, MOD-2021-353249, MOD-2021-353252, MOD-2021-353261, MOD-2021-353569, MOD-2021-353578, MOD-2021-353593 (Patient Link).
dry skin around eyes two weeks after receiving the vaccine; swollen eyes two weeks after receiving vaccine; neck itches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (dry skin around eyes two weeks after receiving the vaccine), EYE SWELLING (swollen eyes two weeks after receiving vaccine) and PRURITUS (neck itches) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY SKIN (dry skin around eyes two weeks after receiving the vaccine), EYE SWELLING (swollen eyes two weeks after receiving vaccine) and PRURITUS (neck itches). At the time of the report, DRY SKIN (dry skin around eyes two weeks after receiving the vaccine), EYE SWELLING (swollen eyes two weeks after receiving vaccine) and PRURITUS (neck itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Blisters appeared on lower left ribcage. Extreme itching. Went to ER 12 hours later and after checking with pharmacy and oncall infectious disease specialist at the ER doc prescribed Valacyclovir(1000mg X 3)
4/10/2021    was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  pain to back across shoulder blades.   Assessment : Time of assessment 425pm. Alert and oriented.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN. 425pm VS - BP- 126/68, P- 64, O2- 100%, 440PM- 115/78, p- 68, O2-100%     Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.       Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/10/2021  4:00 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: EP7533   NDC: 59267-1000-2
After vaccination on April 12 had nausea and vomiting, chills and headache,  stomachache most of the day. At night had fever, pain at injection site, malaise. Same on day2 but milder and headache. Insomnia Day 3 -7chills at day and night time mild headache, sore throat, insomnia Day 7 nausea, chills and headache, tiredness, sorethroat, insomnia Day 8- 10 chills, mouth sores, tiredness, insomnia On eAch day took antihistamine cetrizine
headaches in the night; swollen; arm start itching; red; like a rash; felt a little hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt a little hurting), PERIPHERAL SWELLING (swollen), INJECTION SITE PRURITUS (arm start itching), INJECTION SITE ERYTHEMA (red) and INJECTION SITE RASH (like a rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN (felt a little hurting). On 11-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen), INJECTION SITE PRURITUS (arm start itching), INJECTION SITE ERYTHEMA (red) and INJECTION SITE RASH (like a rash). On an unknown date, the patient experienced HEADACHE (headaches in the night). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (felt a little hurting), PERIPHERAL SWELLING (swollen), INJECTION SITE PRURITUS (arm start itching), INJECTION SITE ERYTHEMA (red), INJECTION SITE RASH (like a rash) and HEADACHE (headaches in the night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Had the vaccine on feb 4th, came home was ok. Monday felt a little hurting. Last Thursday after 1 week had her arm start itching, red, swollen, and like a rash. It stills today. Had a lot of headaches in the night. She wants to have the second dose. Has hot arm, rash, swollen. as the rash goes down the arm, the swollen follows the rash.
Skin reaction of localized redness 2 inch by 2 inch and induration at injection site.
Injection site became hot and inflammed. Patient experienced severe joint pain and headache. The joint pain lasted 2 days. The patient also had a loss of appetite. Symptom resolved after a few days.
Patient received a first and second dose of Moderna; then mistakenly received a 3rd dose of Pfizer.
Right arm started to ache around 2:30 pm while writing on the board (I am a teacher).   It also started to itch.  By the time I got home the injection site swelled.  It was in an oval shape 2 inches long by 1 inch wide.  The area became progressively hot and feverish feeling, sore and swelled so that it felt like a knot under the skin.  I took ibuprofen and iced it.  I was eventually able to sleep.  Today, which is the next day at 8:30 am, I am very tired.  The swelling has gone down and it is still quite warm.