chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt's mom noticed redness @ inj site 18FEB96;MD exam 21FEB96: small palpable knot in muscle @ inj site;area surrounding in a 3cm x 4cm macular circular patchy red rash w/some white areas;not warm, pruritic;localized cutaneous red rash @ site
20JUL loss of appetite, lethargy, sl fever 21JUL; fever 105, vomit, high pitch painful cry 22JUL fever, lethargy, encephalaphy, no appetite; pt was on a respirator by 5PM; many test done;8AUG95 several szs, control w/meds
Dizziness - one half hour after injection. Nausea - lasted 3 hours (severe). Headache - dizziness lasted (7) days.
Pt states palpitations.  PT monitored, VS at released from observation area were normal for this patient.
A few days after I received the first Moderna vaccine, after I was out in the cold with gloves, bumps and swelled areas appeared on the fingers of both hands, on the bottom side (palm side). This had never happened to me before. These lesions persisted for a few days ie probably less than a week, and some of the bumps became raw at the tops before healing. They went away but have reappeared twice since, at least once on what appeared to be exposure to cold (with gloves). My latest batch appeared this past Thursday and is still evident although it is fading. It has affected primarily my right hand, on both the top and bottom sides of the fingers and also one small red spot on  the top of the hand.
The Patient was given the vaccine on 11/28/06 and his mother says that he started to have neck swelling and neck pain 11/30/06.  They presented for medical care on 12/1/06 and the patient was noted to have bilateral parotid swelling, right greater than left.  The also had enlargement of the anterior cervical lymph nodes in his neck and submandibular nodes.  We were unable to express any secretions from his parotid gland, and he did not have parotid tenderness.  There was no fever.
Vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, 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: VERTIGO (non-serious), outcome "unknown". Additional information: I also know of another person who had vertigo of towards, but it wasn't as serious as mine. The shots seem to do as much damage as covid, so I think it is a toss up.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
After patient received Flu vaccine in left deltoid, immediately after complained of severe itchiness in middle of arm below injection site.  Patient notified me today that soreness started about an hour after being observed and examined by provider that same day.  Soreness and pain began to worsen and radiated down left  and a raised red itchy rash developed on left arm where the itchiness occurred. Patient advised to come in and be seen by physician. As patient is examined by physician today, a red streak was noticed in the inner left antecubital area going down left forearm.
Local Reaction o hives, itchy, red R arm/L arm   Systemic Reaction  o neck, scalp, stomach, arms: hives, itchy; runny nose, scratchy throat Pt reported reaction started just under 2 hrs post covid vaccine, and had not resolved at time of call 3.5 hours later
Received second dose on 2/26/2021  Most concerning is Covid Arm   Red, swollen, hot to touch. Covers left arm from site of injection approx 3? wide 6? long. Appears to be moving downward. At its worst  on 2/29. Still warm to touch and red today 3/3  I applied Benadryl itch stop to arm and began taking 1 tablet of Benadryl twice daily  Other reactions of chills, slight fever, and fatigue were expected.
Chills, nausea, vomiting -> dehydration, numbing around lips, trouble swallowing, tightness and redness of throat.
5 day expired Pentacel was administered to a patient; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old female patient who experienced 5 day expired pentacel was administered to a patient, while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HEPATITIS B VACCINE RHBSAG (HEPA-B) for Immunisation.  On 01-Aug-2019, the patient received a dose  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5464AA via unknown route in the left thigh.  The patient developed a non-serious 5 day expired pentacel was administered to a patient (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was 5 day expired pentacel was administered to a patient.    It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Applicable for 5 day expired pentacel was administered to a patient.
No additional AE reported; Nurse reports products that experienced temperature excursion over the weekend were administered to a patient. Products were administered 2/13/2023.       ?    Names of vaccines involved (including lot/exp) PEDVAX HIB W015926 2/14/2025; ROTATEQ 187; This spontaneous report was received from a registered nurse referring to a patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 13-FEB-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1879875, expiration date 19-NOV-2023; strength, dose were not reported)orally and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # W015926, expiration date 14-FEB-2025; strength, dose, route were not reported) for prophylaxis. The vaccines experienced temperature excursion above 9 degree Celsius (13.25 degree Celsius) for 2 hours 32 minutes and 0 seconds (product storage error). There was no previous temperature excursion. No adverse event was reported.
No additional AE details provided; Medical assistant calling would like to know if PROQUAD administered to a 14 year old counts as a valid dose.; This spontaneous report was received from a medical assistant and refers to a 14-year-old female patient. The patient's concomitant medications included hepatitis a vaccine inact (HAVRIX) and polio vaccine inact 3v (vero) (IPOL POLIO VACCINE). Concurrent conditions, pertinent medical history and drug reactions or allergies were not reported.  On 18-APR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, administered subcutaneously in the left arm, lot # U019289 was confirmed to be valid, expiration date 15-DEC-2022 (strength and exact dose not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event details provided (no adverse event).
Pt was found unresponsive in crib, EMS was called, CPR started. Pt received 20 doses of epinephrine and 90 minutes of CPR before calling time of death.
Rec'd H1N1 injection to R Deltoid. Five minutes after receiving vaccine, developed hive on face/neck. Sent to ER. 25 mg IM BENADRYL given.
Pt was seen 06 days after vaccination as per protocols. Pt had normal reaction at this time. Pt came back in at 14 day mark and presented with erythema, pruritis, and satelite lesions. Skin was warm, with eryhtma spreading from vaccine site to axillary area with noted adenoapthy. Pt was afebrile. Nodule at vaccination site is 3 cm, raised, and ulcerated 1 mm at the center, Site is concurrent with that of a major reaction to the smallpox vaccine. Pt dx with cellultis and given 150 mg Clydamycin, take two tabs po qid times 10 days. SIQ for 24 hours. Pt came back on day two and three with marked improvement of the site. Site is healing as per smallpox immunization standards.  A culture has been taken, awaiting results.
severe pain in the feet/"aching"/ "pain is crazy"; cramping; "bone hurts"; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-122190) on 21-Jul-2021 and was forwarded to Moderna on 21-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in the feet/"aching"/ "pain is crazy"), MUSCLE SPASMS (cramping) and BONE PAIN ("bone hurts") in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced PAIN IN EXTREMITY (severe pain in the feet/"aching"/ "pain is crazy"), MUSCLE SPASMS (cramping) and BONE PAIN ("bone hurts"). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (severe pain in the feet/"aching"/ "pain is crazy"), MUSCLE SPASMS (cramping) and BONE PAIN ("bone hurts") outcome was unknown.        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.   Concomitant medication included cholesterol medication.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Non-significant follow-up: Follow up document contain no new information
booster; after taking the vaccine later that day her legs hurt so much; Exhausted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Sep2021 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation; ofatumumab (KESIMPTA) (Batch/Lot number: unknown). Relevant medical history included: "her legs hurt" (not ongoing); "exhausted" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1), administration date: 2021, for COVID-19 Immunisation; BNT162B2 (Dose 2), administration date: 2021, for COVID-19 Immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 29Sep2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2021, outcome "recovering", described as "after taking the vaccine later that day her legs hurt so much"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Exhausted".  Additional information: This report was received based on the information received by Pfizer from Novartis (manufacturer control number: VSC2021US016261_NS). Clinical Course:  Patient reported that she initially started Kesimpta in Jan2021. Patient reported that the COVID-19 vaccine opened up for her group and she consulted with her HCP who advised her to stop Kesimpta in preparation for receiving the COVID-19 vaccine. Patient reported that she stopped Kesimpta, and weeks went by without receiving an appointment for her COVID vaccine. Patient contacted the Health Department and was told it would be weeks or months before she would get it the COVID-19 vaccine. Patient then contacted her HCP who told her to restart Kesimpta, which she did. Patient reports she was then contacted by the Health Department to get her COVID-19 vaccine and therefore she stopped Kesimpta again per HCP. Patient reported she had her first dose of the COVID-19 vaccine and then three weeks later had the second dose of the COVID vaccine. Patient reported it had been three weeks since the second dose of her COVID-19 vaccine and she was told to wait for three weeks before restarting Kesimpta. Patient restarted Kesimpta on 03May2021 and restarted with the monthly dosing schedule per HCP. Update 07Oct2021: Patient talked about this again during today's call and reports that she had the 3rd dose of the COVID-19 vaccine on 29Sep2021, she reported after taking the vaccine later that day her legs hurt so much, she went to sleep and when she awoke the next day she felt better but has been exhausted since getting the vaccine. She reported that she had also been doing so much lately, and this may be contributing to how she feels, and she has felt this way in the past also. Patient's most recent dose of Kesimpta was 24Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 12/24/99, the pt experienced zoster on the right side of the forehead that progressed into the eye. The pt experienced photophobia with full-blown zoster down to the tip of the nose. He also experienced pain in the eye, as well as vesicles on the forehead following the trigeminal nerve. The pt was seen by a physician. The pt was prescribed Zovirax. The pt recovered completely from the experience seven days after the onset of zoster.
Client stated, "My vision became blurred and I felt spinning."  Client given water and crackers. Symptoms lasted less than 2 minutes and then went away completely. Had TDAP 5/26/21 without any reactions.
INR has been fluctuating; This spontaneous case was reported by a consumer and describes the occurrence of INTERNATIONAL NORMALISED RATIO FLUCTUATION (INR has been fluctuating) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 32L20A) for COVID-19 vaccination.     Concurrent medical conditions included Coronary artery disease. Concomitant products included blood thinners and medication for coronary artery diseases for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERNATIONAL NORMALISED RATIO FLUCTUATION (INR has been fluctuating). At the time of the report, INTERNATIONAL NORMALISED RATIO FLUCTUATION (INR has been fluctuating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
9 minutes after injection complained of a pounding headache and dizziness. Given juice to drink that didn't help. Complained of tongue feeling weird. Denied shortness of breath. Transported to ER via transport chair. On way to ER complained of chest pressure in the middle of her chest. Report given to RN in ER. Left in care of ER staff about 15 minutes after injection.
No additional adverse effect reported; a male patient received improperly stored VAQTA; on 11/5/2019, a male Patient received improperly / expiration date was validated to be 05-MAY-2019; This spontaneous report was received from a medical assistant and refers to a 5-year-old male patient. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 05-NOV-2019, the patient was vaccinated with a dose of improperly stored, expired dose of hepatitis a vaccine, inactivated (VAQTA) vial 25/0.5 (units not provided), lot # S009562, expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019, for prophylaxis. No additional adverse effect was reported.  The vaccine was stored in 47 degrees Fahrenheit (F) for 1.39 h. The previous temperature excursion was in above 47 F for 13.35 h. The improper storage was recorded by Digital Data Logger.
difficulty in breathing; chest pain; numbness; severe headache; nausea; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced difficulty in breathing, chest pain, numbness, nausea and severe headache on an unspecified date. Event took place after use of product. The outcome of events was unknown.  Information on the lot/batch number has been requested.
No additional AE,; temperature excursion, caller disclosed that multiple doses of MMRlI were administered to multiple patients; This spontaneous report as received from an office administrator refers to a 12-month-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.    On 08-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status rHA) 0.5 ml injection,"once", lot # S012944 was confirmed to be valid, expiration date 28-APR-2021 (route and site of administration were not reported) for prophylaxis. There were previous excursions reported. The digital data logger was involved. No additional adverse events were reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2101USA000852: US-009507513-2012USA012763: US-009507513-2101USA000854:
Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 67 years old patient who was vaccinated with an expired dose of TENIVAC (lot: U5525AA, expiry date: 07-Jan-2019) in the left arm on 03-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. It was reported that the patient came for an abrasion on her right arm and received an expired dose of TENIVAC. It was unknown whether the patient had any adverse event. 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 Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Soreness at injection site the day after the 1st injection. Chills the night of the 2nd injection. Fatigue the next morning. Face rash (similar to poison oak) started several hours after the 2nd injection and lasted 1 week.
Large lump at injection site; Hot; Can barely lift arm; Hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Large lump at injection site), VACCINATION SITE WARMTH (Hot), LIMB DISCOMFORT (Can barely lift arm) and VACCINATION SITE PAIN (Hurts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Large lump at injection site), VACCINATION SITE WARMTH (Hot), LIMB DISCOMFORT (Can barely lift arm) and VACCINATION SITE PAIN (Hurts). At the time of the report, VACCINATION SITE MASS (Large lump at injection site), VACCINATION SITE WARMTH (Hot), LIMB DISCOMFORT (Can barely lift arm) and VACCINATION SITE PAIN (Hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No Treatment medication information was provided.
severe inflammatory response, specifically in R knee; severe inflammatory response, specifically in R knee. Largely swollen, severe pain, unable to bend; Woke up after second dose with severe inflammatory response, specifically in R knee. Largely swollen, severe pain, unable to bend; Woke up after second dose with severe inflammatory response, specifically in R knee. Largely swollen, severe pain, unable to bend; This is a spontaneous report from a contactable consumer.   A non-pregnant 31 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 01Apr2021 14:00 (Batch/Lot Number: EP7534) as dose 2, single for COVID-19 immunisation.  Medical history included covid-19 from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient previously took BNT162B2 dose 1 on 12Mar2021 for covid-19 immunisation, BIAXIN and experienced allergies.  The patient woke up after second dose on 02Apr2021 with severe inflammatory response, specifically in R knee. Largely swollen, severe pain, unable to bend. It's been almost 2 months since second dose and have been in physical therapy for weeks trying to repair the knee. The outcome of the events was not recovered.
Achiness; Chills; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Achiness) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (One year ago) in 2020.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Achiness) and CHILLS (Chills). At the time of the report, PAIN (Achiness) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2021-405275 (Patient Link).
patient received first dose on 11MAY2021 and second dose today which is more than 42 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 11MAY2021 and second dose today which is more than 42 days ago) 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 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 11MAY2021 and second dose today which is more than 42 days ago). On 27-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 11MAY2021 and second dose today which is more than 42 days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.