chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unable to lift right arm; soreness; red blotchiness on right upper arm; tiredness; high fever; indication: flu prophylaxis; This spontaneous report was received from a 70-year-old female patient, referring to herself. Her concurrent condition included thyroid disorder, acid reflux and high blood pressure. Her concomitant therapies included levothyroxine sodium, omeprazole, and losartan potassium (reported as losartan) (manufacturer unknown). Her history condition and drug allergies were unknown.   On 22-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route of administration, batch/lot# and expiration date were unknown) in the right upper arm for flu prophylaxis (product use in unapproved indication).   On the same day, the patient experienced a high fever, red blotchiness on right upper arm, soreness, unable to lift right arm and tiredness. The patient sought medical attention by contacting physician. No therapies were given to events. On 27-SEP-2020, the patient recovered from the events.  The causalities between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not reported.
Fever, chills, vomiting, dry heaving, diarrhea, loss of appetite
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 37-year-old female patient who received DTPa (Reduced antigen). On 24th November 2016, the patient received DTPa (intramuscular). In November 2016, less than a week after receiving DTPa, the patient experienced injection site coloration. On 25th November, the patient experienced injection site swelling, injection site redness, injection site warmth and injection site pain. The patient was treated with prednisone. On an unknown date, the outcome of the injection site swelling, injection site redness, injection site warmth, injection site pain and injection site coloration were not recovered/not resolved. The reporter considered the injection site swelling, injection site redness, injection site warmth and injection site pain to be almost certainly related to DTPa. It was unknown if the reporter considered the injection site coloration to be related to DTPa. Additional details were received as follows: The patient received a dose of TDaP on the left deltoid and after approximately 24 hours her left arm became red, swollen, painful and hot to the touch. An area of approximately 4 inches around the injection site was noted to be black and blue. On 30th November 2016, the patient visited her local medical doctor and was prescribed Prednisone for the reaction. The reporter did not administer the vaccine and did not know the brand of TDaP administered. The reporter has provided the information he had and would call if able to determine the brand involved.
Injection area developed 7X7 cm circle of redness, warmth and swelling as well as discomfort.
MAJOR HEART ATTACK; This spontaneous report received from a consumer concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, she had major heart attack and died. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The reporter and company provided causality between Covid-19 vaccine ad26.cov2.s and major heart attack as possible. This report was serious (Death).; Sender's Comments: - covid-19 vaccine ad26.cov2.s -Heart attack. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: MAJOR HEART ATTACK
Fatigue; Headache; Weakness; Fever; Shivering; Shakes; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, several hours after receiving Shingrix, the patient experienced injection site pain, fatigue, headache, weakness, fever, shivers and tremor. In September 2020, the outcome of the fatigue, headache, weakness, fever, shivers and tremor were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, fatigue, headache, weakness, fever, shivers and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 6 weeks ago sometime in September and within a couple of hours she developed injection site pain that lasted for 3 days and then resolved. The patient stated that about 12 hours after receiving dose woke up feeling fatigue, headache, weakness, fever, shivering and shakes. All these symptoms resolved within one day. The reporter did not consent to follow up and declines follow up for this adverse event.
This spontaneous report as received from a healthcare worker refers to a number of unspecified patients (demographics unknown). On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route and lot number were not reported). Concomitant medication was not reported. The doses of RECOMBIVAX HB were exposed to a lowest temperature of 24.2 F for "42 minutes". The healthcare worker will confirm the actual time that the vaccines were below 36F, since it was unlikely that the total time below 36 F was only 1 hour. No adverse effect was reported. This case is linked to MARRS# 1401USA002521 and 1401USA003228 by the same reporter. Additional information has been requested.
Extreme pain and cramping, blood clots and still having my period since the first of April.
24 hours after vaccine, patient had a central locally tender, red, slightly indurated area at varivax immunization site.
Information has been received from a Doctor of Pharmacy (Pharm. D.) student concerning a 27 year old female with no medical history or drug allergies who on an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL. There was no concomitant medication. It was reported the patient developed a widespread petechial rash after administration of the vaccine. The reporter is unable to provide the dates of administration of GARDASIL or the date of onset of the rash. The patient sought medical attention. She was seen in a hospital emergency department on 24-MAR-2009 and was treated with BENADRYL and prednisone. The patient was released from the emergency department and did not require hospitalization. At the time of reporting the patient was not recovered. No further information is available.
1/14/22 pm:  onset of fever, abdominal pain, nausea, vomiting with cough on 1/15/22.  Fever resolved 1/15/22, but abdominal pain and nausea vomiting worsened until vomiting became intractable 1/17/22 pm and patient taken to ED early morning 1/18/22.  She was diagnosed with PANCREATITIS and admitted to floor.
After taking my first dose, I felt lightheaded.  It lasted about 10 minutes.  After taking it the next week, my arm was sore and a bump was visible.  It stayed for two days.  Then it would go down, then raise again accompanied by itching.  Then it went away.  No treatment.  I did put lotion on the itching site.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 21-APR-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning an 11 year old female who on 01-MAY-1996 was vaccinated with a first dose of Varivax. Concomitant vaccination included a first dose of MMR II. On 12-APR-2006 the patient developed a "bad case" of breakthrough chickenpox disease. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was available. The patient's additional vaccination history includes: first, second, third and fourth doses of diphtheria toxoid (+) Hib conj vaccine (CRM197) (+) pertussis whole cell vaccine (+) tetanus toxoid (manufacturer unspecified) on 05-JUN-1995, 21-AUG-1995, 20-OCT-1995, and 30-JUL-1996 respectively. First, second, third and fourth doses of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unspecified) on 08-APR-1995, 05-JUN-1995, 30-JUL-1996, and 29-AUG-2001 respectively. One dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (manufacturer unspecified) on 05-JUN-1995. Doses of influenza virus split virion 3v vaccine inactivated on 04-DEC-2000 (FLUSHIELD) (lot # 4008210). On 09-NOV-2004 (FLUZONE) (lot # U1515AA), and 29-NOV-2005 (FLUZONE) (lot # U1916AA). One dose of poliovirus vaccine inactivated (unspecified) (IPOL) (lot # R1366) on 21-AUG-2000. A second dose of MMR II (lot # "0577") on 21-AUG-2000. First, second and third doses of poliovirus vaccine live oral (manufacturer unspecified) on 05-JUN-1995, 21-AUG-1995, and 30-JUL-1996 respectively. First and second doses of Infanrix on 21-AUG-2000 (lot # U0137BA) and 15-JUL-2005. Additional information is not expected.
Initial report received on 24 March 2010 from a consumer. A 38 year-old male patient with a medical history significant for gout and allergy to hydrocodone received 5 doses of vaccine and immune globulin. At the time of vaccination the patient denied illness but reported being bitten by a bat. A questionable amount of vaccine was given, some doses of vaccine were given into gluteal. The reported date of vaccination was 15 August 2009 with IMOVAX (lot # not reported) and immunoglobulin human antirabies (manufacturer and lot # not reported). It is not known whether this date was the first date for the IMOVAX series. The patient complained of joint pain in hip for a day or so after each injection. He also developed a rash in axillary and groin area a few weeks following receipt of the series. Additionally, the patient developed a severe headache on 12-13 October 2009 that persisted. The patient reported receiving influenza vaccine (manufacturer and lot # unknown) a few weeks prior to the onset of the headache. The patient did not recover from the adverse events at the time of the report. No other information was provided. List of documents held by sender: None.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. The pharmacist reported that the cap on a vial of ZOSTAVAX was flipped in the pharmacy prior to attempting to vaccine te a patient. Because the cap was flipped the pharmacist did not give the patient the dose because he wanted to check first. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Patient's outcome was unknown. Additional information has been requested.
Anterior Ischemic Optic Neuropathy; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.  On or around 28-SEP-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered sudden visual loss of his right eye and was diagnosed with anterior ischemic optic neuropathy in his right eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had results in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of the event was unknown. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, the event anterior ischemic optic neuropathy was considered to be medically significant. The event was also considered to be disabling by the reporter.
Pt. got H1N1 shot on 11/12/09 around 10:30 A. Later that night pt. became very tired, and begin to experience bad headaches, Friday as of today pt developed horrible sore throat, trimmers. Pt still has headache.
Hives occurred 5 to 7 days after shingles vaccine on sides of neck and other places shingles would appear.  Was taking NITROFURANTOIN MACROCRYSTAL for 3 months prior with no issues.  Stopped taking this "MACROBID".  Symptoms eased up.  But still getting the hives in the evening; they are gone by AM.
The vial was initially stored in the refrigerator on 11-Jan-2023 and was administered on 15-Mar-2023; No adverse event; Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2023 and was administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-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 15-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2023 and was administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2023 and was administered on 15-Mar-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2023 and was administered on 15-Mar-2023).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. The 2.5ml individual vial did not underwent any temperature excursions No treatment information was provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720395:Same reporter
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A elderly female patient (over age of 65) of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in the arm, on an unspecified date in Oct2016, at 0.5 ml single, for immunisation and FLUZONE, via an unspecified route of administration in the arm, on an unspecified date in Oct2016, at a high dose, for immunisation. The vaccines were administered in different arms. The patient's medical history and concomitant medications were not reported. In Oct2016 the patient experienced pain injection site, muscle pain, chest pain and heaviness on her chest all with outcome of recovered in Oct2016. The patient presented to the emergency room and was later discharged. No follow-up attempts possible. No further information expected.
HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional.   Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable.   Further information is expected.  For reference purposes, this case is linked to MCM-004406, MCM-004408, MCM-004407 and MCM-004410 (same reporter).  SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable.  No further information is expected.
p/3hr had t100.9 & crying ever since rt leg site of  immun warm to touch not red hardened area & cries as soon as touched;
1/5/22 43 yr/o  female with a past medical history of cervical cancer, anemia, hepatitis and UTI presenting to the Emergency Department with the chief complaint of left lower quadrant pain x3 weeks.  She was recently diagnosed with COVID-19.  She says she did not feel any symptoms related to her COVID-19.
I have received the 2nd dose of the moderna vaccine in my left arm.  I now have a swollen knot at the injection sight.  It is very painful and itching.
Patient tested positive for Covid-19 on 11/5/21 and died on 12/16/21
Pt returned to clinic with mother ~4pm on day of vaccine administration.  Per mother, child had been crying >3hrs straight after vaccine administration.  On exam, baby was intermittently crying and appeared uncomfortable, but she was consolable when held.  Heart and lung exam remained unchanged from above, apart from mild tachycardia, likely 2/2 discomfort.  Temp 98.9.  B/l thighs were mildly erythematous, moderately edematous without pitting, and seemingly tender to light palpation.  Overlying skin somewhat taut.  Child remained warm and well-perfused with 2+ distal pulses b/l.   Child was given acetaminophen and diphenhydramine.
Information was received on 24-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX on or about 10-NOV-2015, administered by his physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent  strain of herpes zoster. On or about 22-NOV-2015, the patient was on vacation when she was rushed to an urgent care center for treatment of a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir (manufacturer unknown) for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Additional information has been requested.
Information has been received from a pharmacist concerning a 53 year old female patient with no known medication allergies, diabetes mellitius, hypertension, a hearing aid and arthritic pain who on 11/01/2002, was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643783/0709M).  One hour post vaccination on 11/01/2002 the patient returned to the doctor's office complaining of increased swelling of her arm and pain at the injection site.  The reporter indicated there was no redness or swelling noted and there was slight pain to palpation.  The patient was treated with moist heat and over the counter nonsteroidal anti-inflammatories.  At a later point, the patient presented to the ER complaining of increased swelling and redness.  The patient was treated with antibiotics and narcotics.  On 11/04/2002, the patient recovered.  The reporter noted that the patient had no adverse events following prior vaccination.  The reporter had previously reported another adverse experience (WAES # 0211USA00944) with this same lot number and is requesting a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information is not expected.
Temp 101.2 an hour after receiving MMR -V combo. T max 103.9 about 8 hrs after vaccine administration and had 4 seizures in a row. Was hospitalized x 4 days due to increase temp. No other seizures per Mom.
After receipt of her 2nd dose of the Moderna vaccine, the patient complained of her eyes feeling swollen. She also had hives her back. She was provided an icepack in the monitoring area for her eyes and was observed. She denied itching or throat tightness. Due to increasing hives and additional eye edema, she was taken to the ED. At the ED, she was examined and no hives were found upon examination, only a small area of redness on her chest. Patient was administered one dose of 50mg Benadryl in the ED. She was discharged and counseled to return for worsening signs/ symptoms which were described to patient.  The patient indicated understanding and was advised to take Benadryl for symptom relief and follow up with her doctor within 1-2 days for worsening or continued problems. The patient discharged to her home.