chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 02-DEC-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
dose 1 administered on 11/3/2022 and  dose 2 administered on 12/15/2022; No adverse event; Expiration date was 13JUL2022 and administered on 3NOV2022 and 15DEC2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expiration date was 13JUL2022 and administered on 3NOV2022 and 15DEC2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1 administered on 11/3/2022 and  dose 2 administered on 12/15/2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Dec-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expiration date was 13JUL2022 and administered on 3NOV2022 and 15DEC2022). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1 administered on 11/3/2022 and  dose 2 administered on 12/15/2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expiration date was 13JUL2022 and administered on 3NOV2022 and 15DEC2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1 administered on 11/3/2022 and  dose 2 administered on 12/15/2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expiration date was 13JUL2022 and administered on 3NOV2022 and 15DEC2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1 administered on 11/3/2022 and  dose 2 administered on 12/15/2022).    No concomitant medicine were reported. No treatment medicine were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-703832, US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: The IRD of deletion case is 23-Jan-2023. On 24-Jan-2023: Live Significant FU : Reporter qualification updated and Narrative updated On 24-Jan-2023: Live Significant FU : Patient identifier details added. Upon the receipt of the follow-up information on 23-Jan-2023, it was identified that the information in cases MOD-2023-703832 and MOD-2023-703265 are pertaining to the same patient and same product. Hence the case MOD-2023-703265 will be retained for further follow-up and all the information from the case MOD-2023-703832 has been incorporated into the retained case MOD-2023-703265. The case MOD-2023-703832 will be deleted from the safety database. On 24-Jan-2023: Reporter qualification updated and Narrative updated On 24-Jan-2023: Patient identifier details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703832:Patient 1 US-MODERNATX, INC.-MOD-2023-704260:Master case
While on a trip, I noticed I felt like I was coming down with a cold, I had fatigue and body aches with a little brain fog.  6/1 returned and was just exhausted. 6/2 Tested with an At Home COVID-19 test that was expired. Negative result, but my throat started to hurt. I slept all day, very fatigued. On 6/3 I got a new at Home COVID-19 test, positive. I went to Urgent care at that time. I was tested again with a Rapid COVID-19 test, positive. They also tested for Strep and Flu, negative. Doctor prescribed a lighter dose of Paxlovid due to past kidney disease, and Icguaifen Codeine. Started Paxlovid 6/3 and cough syrup 6/4. Cough got really bad on 6/4 and I stayed in bed while taking Extra Strength TYLENOL as often as possible. 6/5 symptoms were diminished and only needed to take TYLENOL once, and so far not at all on day of reporting.
shot 1 in November 2020, has not received shot 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had mild case of shingles during pregnancy). Previously administered products included Shingrix (1st dose received intramuscularly in an unspecified deltoid during the first week of November 2020 ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix and was past the 6 month window, which led to incomplete course of vaccination. The reporter did not consent to follow with physician. The VAERS detail provided for 1st dose of Shingrix.
This case was reported by a consumer and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient had mild reaction when received a dose of SHINGRIX. For tolerance to 2nd dose, refer case US2018GSK211209.
The patient got a headache the night of the first shot. It lasted for 18 days. She described it as sitting at her front under her forehead where it then travelled to the back of her head and became a migraine. It was unalleviated by medication.
gave Daptacel to a 7-year old; Initial information received on 24-Jul-2019 regarding an unsolicited valid non-serious case received from a physician Assistant.  This case involves a 7 years old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history and family history were not provided. The patient did not receive any concomitant medication.   On 23-Jul-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number, expiry date not reported via unknown route in unknown site.  It was an actual medication error due to inappropriate age at vaccine administration. It was reported that gave Daptacel to a 7-year old patient.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on batch number was requested for this case.
Rec'd imm. at WCE on 9-16-14. Light red rash to (Rt) upper arm began 9-17-14 and increased in size -> office visit on 9-18-14. (S/S = warmth, erythema and induration to (Rt) deltoid approximately 8 x 7cm; no fever or c/o pain). Monitor area, return if s/s increase.
Vaccine recipient received vaccine on 1/10/2021 and reported severe fatigue. She woke in the middle of night with severe bilateral leg pain, similar to sciatica, painful to get out of bed and walk, similar to Charlie Horse. She took Tylenol and laid around most of the day 1/11/21. Pain in right leg stopped in evening on 1/11/21, however pain continues in left leg. Nerve pain in left leg is still continuing from left gluteal muscle to inner thigh above knee cap. She declined occupational health follow-up and will self-manage at home. Pfizer-BioNTech COVID- 19 Vaccine
COVID 01/18/2021, Awoke with sore throat and head cold that morning and called Dr. office for test. They sent her through their drive thru testing site, COVID PCR test and 01/19/2021 results was positive. Was give quarantine instructions and self care instructions and directive to contact if any worsen effects occurred.
LEG SWELLING ON SAME SIDE OF BODY WHERE INJECTED WITH VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced leg swelling on same side of body where injected with vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leg swelling on same side of body where injected with vaccine was not reported. This report was non-serious.
patient had a seizure within the hour of receiving vaccines. Mom called Drs. office, spoke with Dr. and was advised to take patient to Emergency Room.
Area appeared red and slightly raised. Shot was given Saturday 8/12/00 and pt in to see doctor on Monday 8/14/00. Treated with antibiotics and pt to return in 3 days for recheck. On 8/17/00 there was no redness on arm.
Just acute arm pain after first vaccine After the second vaccine, I experienced horrible menstrual cramps and heavy bleeding (very unusual).  I've had 3 periods since my second vaccine, and I am still experiencing menstrual changes- very painful cramping prior to actually getting my period.  This is uncommon.  I usually have slight cramps after bleeding for a short period of time, but the last 3 periods I've gotten really painful cramping before.  The cramps start about 3 days before, and have continued for at least 2 days once I've started my period.
This spontaneous report was received from an elderly (over 65-year-old) female patient, who was reporting on herself. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date in approximately 2012, reported "as about 5 years ago", the patient was vaccinated with PNEUMOVAX 23 injection (strength, dose, route of administration, lot # and expiration date were not reported). The patient said that within the past 5 years, she received a ZOSTAVAX vaccination, 19400 plaque-forming units (PFU) vial (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced an unspecified condition and at the time of reporting she was taking an unspecified new medication for this condition. On an unknown date, the patient had trouble remembering her phone number. The outcome of the events was not reported. The relatedness between the events and the suspect therapies was not assessed by the reporter.
Narrative: COVID infection after completion of COVID vaccine series 12/18/2020 COVID infection with hospitalization 03/25 COVID vaccine dose #1 03/26 pt reports feeling woozy after vaccine, having back weakness and not walking well, had one fall, reports getting rash to bilateral groin area (does wear depends) 04/15 COVID vaccine dose #2 04/16 wife reports pt very weak standing, trouble standing and breathing heavy due to weakness, laying in recliner 04/19 pt feeling better 05/09 wife reports pt w/ severe shoulder pain and legs starting giving out, urinary retention x 10 hrs, reported weakness x 1 week, covid positive, admitted to hospital 05/11 discharged from hospital
Benign paroxysmal positional vertigo, bilateral (vertigo when laying in bed, lasting +/- 30 seconds, occuring a few times per week, continuing for several weeks)
Chest pain, swelling face, SOB, on wheezing - Tx prednisone 50 mg until wheezing resolve (Hx of asthma) VENTOLIN inh.
The patient came in to the pharmacy complaining of redness and swelling at the injection site that occurred beginning the day after the immunization was given. It was probably a few inches in diameter. They complained of no other symptoms. They were informed that they could follow up with a medical provider if the condition worsened or became bothersome.
Information has been received from a medical assistant concerning a 4 year old male with asthma, no other past medical history, and no known allergies who on 04/24/2002 in the morning was vaccinated with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 642230/0181M) in the left thigh.  Concomitant therapy included a dose of varicella virus vaccine live (site unknown)(Lot # 640465/0969L).  Other concomitant therapy included loratadine (Claritin), fluticasone propionate (Flovent), mometasone furoate (Nasonex) and albuterol MDI.  On 05/02/2002 in the AM (also reported as 05/01/2002) the patient developed a rash, described by his mother as a "fine red rash on the chest and back only."  There was no fever or other symptoms reported.  The patient sought unspecified medical attention.  It was reported that the patient recovered.  It was noted that no relevant diagnostic tests or laboratory data were performed.  No further information is expected.
headache; sore throat; not feeling well; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 17Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient inquired if it was okay to take the second dose after 21 days as she was not feeling well, had a headache and sore throat. She reported her first dose was on 17Feb2021 and the second dose would be on 10Mar2021. The clinical outcomes of not feeling well, headache and sore throat were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a medical assistant referring to a 17 month old male patient. No relevant medical history or concurrent conditions were reported. On 28-JUL-2015 the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported; lot# reported as K002939 which was verified as invalid, expiration date 11-DEC-2016) and improperly stored VARIVAX (Merck) (dose and route not reported; lot # reported as L00827 which was verified as invalid, expiration date 11-MAR-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The first 2 days after the Moderna booster were similar to the 2nd dose of Moderna except for the extremely large bump on my arm.   On the 3rd day I experienced slight chest pain.  On the 4th day I had urinated small blood clots in my urine for 6 hours starting at 9a. The first hour they were the size of a quarter for  4 urines.  The next 4 times I urinated they were the size of a dime and then a change to snot like blood.  Then a small color of blood and then by 4p no more blood.  I was tired, called my doctor and was prescribed amoxicillin.  I went to bed early and slept 10 hours.  I felt fine after that.  I am following up with my doctor to check and see if it is bladder related.
Burning sensation to right arm 5 minutes after vaccine administration. Patient experienced dizziness, headache, weakness to bilateral extremities, and elevated BP and heart rate 10 minutes after administration. Patient laid down on exam table supine with both feet elevated for 30 minutes. Symptoms still not resolved and patient was unable to stand up without being dizzy. 25mg Benadryl given PO.   One hour after vaccine administration, patient started to have chills with weakness, headache, and dizziness. Patient was transported to ER.
Information has been received on 16-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-DEC-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, 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 an unknown date, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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 and pain and suffering and other damages. Additional information has been requested.
VERTIGO; RACING HEART; ANXIETY; NOT FEELING QUITE LIKE SELF; TROUBLE SLEEPING AT NIGHT; NAUSEA; FELT TIRED; TINNITUS; NO ENERGY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: glaucoma, and other pre-existing medical conditions included: Patient had no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 23-AUG-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the patient experienced vertigo. On 28-APR-2021, the patient experienced racing heart. On 28-APR-2021, the patient experienced anxiety. On 28-APR-2021, the patient experienced not feeling quite like self. On 28-APR-2021, the patient experienced trouble sleeping at night. On 28-APR-2021, the patient experienced nausea. On 28-APR-2021, the patient experienced felt tired. On 28-APR-2021, the patient experienced tinnitus. On 28-APR-2021, the patient experienced no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo, racing heart, anxiety, not feeling quite like self, nausea, felt tired, and no energy on 23-JUN-2021, and trouble sleeping at night on 11-OCT-2021, and had not recovered from tinnitus. This report was non-serious.
ocular migraine; dizziness (which mainly happens when she looks down); light pressure between her eyebrows; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 19May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Anatomical location: Arm Left, lot/batch number: ER8729), administration date: 28Apr2021, for Covid-19 Immunization, reaction(s): "injection site pain", "injection site swelling/ swelling to her arm at the injection site", "lethargy", "tenderness/ she woke up and was getting dressed and noticed tenderness on her bra line on the opposite side of where she got the vaccine", "(black and blue) bruise on the right side of her bra line". The following information was reported: RETINAL MIGRAINE (non-serious), outcome "unknown", described as "ocular migraine"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness (which mainly happens when she looks down)"; DISCOMFORT (non-serious), outcome "unknown", described as "light pressure between her eyebrows".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
I took the second does of this vaccine about 11pm at night after eating around 9 PM and having 2 beers. I went to sleep at 2 am. I woke the next morning around 10 am. I felt groggy and also was experiencing muscle cramping in my lower abdomen and lower back. I took 400mg of ibuprofen to relieve the cramping and I went back to sleep. I slept until 5 pm that day, and still felt groggy and sleepy. I went to sleep around 1 am. The next day I felt a little sluggish, but overall much better.  However, I have been experiencing loose, runny stools (diarrhea) still, even though I have finished the course of taking this vaccine. I am writing only to report that I experienced side effects, not an adverse reaction. I was able to manage these symptoms at home and I did not require any other medical care. Thus the side effects I experienced were abdominal muscle cramping, extreme fatigue, and diarrhea following day 2 of the vaccine. I believe that I followed the instructions for the vaccine appropriately by keeping it refrigerated and taking the vaccine on any empty stomach with water.
Patient said her arm hurt really bad. She said that she has had other vaccines and it never hurt that bad. It has resolved tho.
Itchy rash across stomach; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 30Jan2021 at 11:15 in right arm as single dose for COVID-19 immunisation. The patient medical history included shellfish allergy and detached retina from an unknown date and unknown if ongoing. Concomitant medication included losartan. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 31Jan2021, 17:00 the patient experienced Itchy rash across stomach. The event was considered as non-serious. No treatment was received for the event. The outcome of the event was not recovered.   Follow-up attempts have been completed and no further information is expected.