chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 1JUL96 4PM & exp t102, sore arm, hallucination;1st noc pt restless;c/o painful arm;1PM t103.6;motrin given;on awakening  began to scream on seeing mom running down hall & acted as if didn't know mom;whiny x 3 days;diff sleeping
Failed to dilute Pfizer pediatric vaccine. Tried numerous times to call patient. No answer. No return call.
mistakenly received his second Shingrix dose six weeks after the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: mistakenly received his second Shingrix dose six weeks after the first dose).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023 The vaccine administration facility was the same as primary reporter. The HCP/reported had limited details (unknown dates, lots, patient identifiers) as she was not at the pharmacy at the time of the call. The patient received 2nd of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up. Nothing else was reported.
Lesions consistent with mild varicella for 3 days mainly on back and neck, 3-4mm red papules with some slightly umbilicated vesicles.
Began to feel poorly about 7 hours post injection.  Basically like I was getting the flu but the onset was very fast.  Within an hour I had severe chills, body aches, headache and shivering.  This lasted for about 6 - 8 hours and then began to subside.  I never registered a fever.  The following day I just felt kinda blah, without a lot of energy but all symptoms were gone.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, he was treated at a physician office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
dark red rash, itchy; dark red rash, itchy; dark red rash, itchy; urticaria develop in 4 staff and 1 client after injections; A spontaneous report was received from a nurse concerning a 52 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site erythema, injection site rash and injection site pruritus.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the events injection site dark red rash that was very itchy.   Laboratory details was not provided.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event injection site dark red rash that was very itchy was unknown.; Sender's Comments:  MOD-2021-012249:Original Case : MOD-2021-011289 US-MODERNATX, INC.-MOD-2021-012249:same reporter, different patient
Thursday he had the chills; Fever of 99 then at night 101; bit more tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Thursday he had the chills), PYREXIA (Fever of 99 then at night 101) and FATIGUE (bit more tired) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Thursday he had the chills), PYREXIA (Fever of 99 then at night 101) and FATIGUE (bit more tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHILLS (Thursday he had the chills) and PYREXIA (Fever of 99 then at night 101) had resolved and FATIGUE (bit more tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (High) 99 and 101 (High) 101.         Concomitant medication was not provided . Patient was in hospital for aneurysm procedure.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow up received on 21-JUL-2021. Patient details added. Treatment medications provided. New events added.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication details was reported. No treatment medication details was reported.
Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INSOMNIA (Insomnia). At the time of the report, INSOMNIA (Insomnia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided.  Treatment information was not provided.
Patient received COVID vaccine at 1048 a.m. Initially reported "throat numbness to medical assistant after 15 minutes of observation. At 1126 patient reports "hot flashes and knot to throat. Epinephrine 0.3 mg administered to left thigh. EMS called and patient transferred to hospital ER per patient request.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (injection, route, dose, injection site and lot number (unknown). On an unknown date, the patient developed adverse effects after receiving the vaccine. The patient experienced burning, and nerve pain, in the vaccinated arm, post vaccination with the PNEUMOVAX 23. The patient called the pharmacy because the sensation was so painful they believed they were having an allergic reaction to the vaccine. Pharmacy called the EMS (Emergency Medical Service) who were sent to the patient's home. EMS determined the reaction the patient was having was not life threatening. The patient was reported as recovered/resolved. This is one of several reports received from the same source. Additional information has been requested.
Pt with previous partial mastectomy and 37 lymph nodes removed on L side. Vaccine was administered to the L arm. She had local pain, chills, fever for 1 day, arthralgias, and then it progressed to erythema, induration, warmth, swelling below the site of the vaccination.
This spontaneous report was received from a doctor in pharmacy concerning to a 65 year old female patient with thiazides allergy, sulfonylureas allergy and carbonic anhydrase inhibitors allergy. On 25-OCT-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that about 10 days ago, in approximately 27-OCT-2012, the patient went to the emergency room (was unspecified and the pharmacist was unsure at the time of the call if the patient was ever hospitalized) complaining of a several headache, swelling and redness of the arm (believed to be injection arm). The patient went to their physician on 05-NOV-2012 and the physician reported to the pharmacist that the patient was slowly resolving. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Within 5-10 minutes after receiving the vaccine, the patient developed facial hives with some itching. Some facial flushing with 1-2 target lesions on the back.
Swollen, puffy eyelid. Never had anything like it before. Dull pain at outside of left eye. Eye feels depressed or sunken. Not as firm or protruding as right eye. Lower eyelid swollen. Painful to blink.
administered a patient a Moderna Covid bivalent booster as the 3rd Covid vaccine/the facility was checking inventory and thinks they may have given the dose from a pediatric vial; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered a patient a Moderna Covid bivalent booster as the 3rd Covid vaccine/the facility was checking inventory and thinks they may have given the dose from a pediatric vial) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 23-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (administered a patient a Moderna Covid bivalent booster as the 3rd Covid vaccine/the facility was checking inventory and thinks they may have given the dose from a pediatric vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administered a patient a Moderna Covid bivalent booster as the 3rd Covid vaccine/the facility was checking inventory and thinks they may have given the dose from a pediatric vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (administered a patient a Moderna Covid bivalent booster as the 3rd Covid vaccine/the facility was checking inventory and thinks they may have given the dose from a pediatric vial).    No concomitant and treatment were provided.
Abnormal menses.  Huge clots.  Velocity and volume of blood extreme.  (Different from previous experiences of menorrhagia).  The only other time I experienced this type of dramatic and concerning bleeding was after I took the Hepatitis vaccine (first shot) about 2 years ago.  I think that's the only other vaccine I've had as an adult.  There is mention of heavy bleeding as a rare side effect for Hepatitis vaccine, and I surely hope you will study this effect from Covid vaccine as it took nearly a year to regulate my cycle after the Hepatitis vaccine reaction.  I've seen some reports suggesting that the excessive bleeding that women are experiencing after the Covid vaccine is due to stress and that is just plain insulting.  Stress does affect the menstrual cycle; that is well-known, but this is something entirely different.  I have also had small clots in the nose during the past several days, which again, is highly abnormal for me.  Thank you for looking into the bleeding side effects that hundreds (if not more) women are struggling with at this time.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 63.5-year-old patient who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number: UJ039AA, expiration date: 15-May-2019) 0.5 ml, via intramuscular route in left deltoid, on 16-Oct-2018. The patient's medical history was not reported. No other vaccine was given. It was an actual medication error due to inappropriate age at vaccination. 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.
pt had 2 3/4 x 2 3/4" area reddened sl edematous where vax had been administered on 7OCT92;
Patient and spouse say that the morning following the vaccination, patient's right arm was sore and red from deltoid past elbow to halfway down forearm. Came to pharmacy, then went to urgent care! Dr prescribed Augmentin 875 twice a day x 14 days. Slight improvement at 4 PM on 10/17/14.
shingles; got her first dose 10 months ago and just got her second today; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number NG5N7, expiry date 1st April 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 29th October 2020, the patient received the 2nd dose of Shingrix .5 ml. On 29th October 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was born in 1963. The patient got her first dose 10 months before time of reporting and got her second on the day of reporting. She had gotten shingles since the first dose and were wondering if it would be recommend a third dose. The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Shortly after providing vaccine patient felt dizzy. No loss of consciousness, just dizzy feeling. Pharmacist instructed patient to lie down. Technician called EMS while pharmacist stayed near patient. Patient described feeling nervous about needles. EMS arrived within 10 minutes to assess. Patient declined additional medical support and left with driver.
8 hrs post injection, arm started to turn red and hot; next morning, arm sore and very red and swollen all above elbow. Three days later, still swollen-moved to elbow. Right arm.
Dose: 1, Date: 15Oct2021; Dose: 2, Date: 15Oct2021; Joint pain...elbows mostly knees & hips Still aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 08:45 (Lot number: Ew0178) as dose 1, single and administered in arm right, administration date 15Oct2021 08:45 (Lot number: Ff2590) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines have lessened greatly" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Oct2021, outcome "unknown", described as "Dose: 1, Date: 15Oct2021; Dose: 2, Date: 15Oct2021"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Joint pain...elbows mostly knees & hips Still aches". Therapeutic measures were not taken as a result of arthralgia.  Additional information: The most recent COVID-19 vaccine was administered at Workplace clinic facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received vitamins and ibuprofen medications within 2 weeks of vaccination. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
IM  given in left arm 3rd dose. (Booster). Moderna Covid-19 Vaccine Lot 045C21A given was removed from freezer on 10/6/21 @ 11:45 am. Given on 11/5/21, out of time range.  Patient contacted that evening. Moderan manufacturer called. Patients called the following Monday letting them know that Moderna was looking into this and would be getting back to us. Also let them know I would be following up with them once we heard back from them.  Called patient today 11/17/2021 and let him know that Moderan let us know the  vaccine was viable, no additional booster vaccine is required.
feeling nauseous; headache; received the expired dose as their second dose of their primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (feeling nauseous), HEADACHE (headache) and EXPIRED PRODUCT ADMINISTERED (received the expired dose as their second dose of their primary series) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Dec-2022, the patient experienced NAUSEA (feeling nauseous), HEADACHE (headache) and EXPIRED PRODUCT ADMINISTERED (received the expired dose as their second dose of their primary series). At the time of the report, NAUSEA (feeling nauseous), HEADACHE (headache) and EXPIRED PRODUCT ADMINISTERED (received the expired dose as their second dose of their primary series) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient did call 30 minutes ago saying she was feeling nauseous and headache. Individual vials or unbroken cartons: 1 vial, 1 dose 4. Vial size was 5 ml. Did the vial undergo any temperature excursions: Not that they were aware. Treatment information was not provided.
Numbness and tingling in my lips and tongue on same side as injection; Numbness and tingling in my lips and tongue on same side as injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 14:00 (Lot number: FC3182) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious) all with onset 27Aug2021 14:15, outcome "unknown" and all described as "Numbness and tingling in my lips and tongue on same side as injection".  Additional information: The agency number and Expiry Date for suspect were not provided. The patient got the first Pfizer Covid 19 shot around 2pm this afternoon and she waited the 15 minutes (after receiving the injection) and left. Shortly after she noticed numbness, tingling around her lips and tongue on the same side as the injection site. She did not know if this was a concern or possible side effect from the vaccine and would like to know. Investigation Assessment was not provided.  No follow-up attempts are possible. No further information is expected.
Developed redness, swelling and pain four hours after vaccine administered. Went to ER and was treated for allergic reaction and released.
Developed funny sensation in cheeks and upper lip, as well as mild swelling of cheeks and upper lip, with onset approximately 17 minutes after Shingrix was administered.  No other symptoms.  Since the swelling was so very mild (almost imperceptible to examiner at onset but did observe reduction in cheek size over time thereafter), close direct observation was chosen.  No other symptoms ever developed aside from high BP (160's/high 90's), which might have been caused by anxiety.  The funny sensation in face and mild facial swelling improved over the course of 20-40 minutes.  Patient was released to return home after 1 hour, and per later reports, her symptoms had essentially completely resolved within approximately 2 hours.
This report describes the occurrence of an anaphylactic reaction in a 44 year old female who was vaccinated with hepatitis A inactivated & hepatitis B recombinant vaccine (Twinrix) for prophylaxis. This report was received from the subject and has been verified by a physician. The subject's relevant medical history included allergy to bee stings (onset in the late 1990's). The subject experienced no adverse events following previous immunizations. Concurrent medications included unspecified birth control medication. On March 13, 2003, the subject received her first injection of Twinrix. On March 13, 2003, at an unspecified time post- immunization, the subject developed an anaphylactic reaction with "closing of airway, difficulty breathing". The subject was seen in the emergency room five times and was admitted to the hospital twice, for strays of one night and two nights respectively. The most recent information was received from the treating physician on May 02, 2003. The physician considered the anaphylactic reaction to be related to Twinrix administered and to have jeopardized the subject of required intervention. The anaphylactic reaction resolved on approximately March 21, 2003. The Twinrix immunization series was discontinued.