chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dec 5 began not feeling well, I was achy, tired, headache, and horrible runny nose. Woke up the next morning feeling much worse, and took an at home test which was almost immediately positive. Had a doctor's appointment that afternoon and was prescribed PAXLOVID. Continued having severe sore throat, low grade fever, fatigue, headache, and cough. Have been fever free since I had the fever on Monday. No shortness of breath or tightness in chest. Woke up today with severe headache and fatigue today. Reached out to PCP and was instructed to isolate for 3 more days and retest. Tested Monday and today. Both were positive.
first dose on 23 Feb 2021 and second doce on 17 Mar 2021; FLAKENESS ABOVE EYEBROW; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (FLAKENESS ABOVE EYEBROW) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 23 Feb 2021 and second doce on 17 Mar 2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 23 Feb 2021 and second doce on 17 Mar 2021). In 2021, the patient experienced SKIN EXFOLIATION (FLAKENESS ABOVE EYEBROW). At the time of the report, SKIN EXFOLIATION (FLAKENESS ABOVE EYEBROW) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 23 Feb 2021 and second doce on 17 Mar 2021) outcome was unknown.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
When I arrived at the clinic, they were well behind on rooming and discharging patients.  Before I was settled in I had the patient sheets and forms for ARNP, schedule for the day, and told the five year old in room 16 needed vaccines.  I was also told by one MA that another MA had pulled what I needed, had it warming on the counter, would be ready at 10:37 am, and it?d be drawn up.  Not having the training and time to fully learn vaccines for pediatrics and not having a MA I could find, I reached out to my clinic for help with the vaccines other than Covid.  Once I was finally ready, I went to the lab and gathered everything but the Covid vaccine.  The Covid vaccine was not drawn so I checked what was on the counter.  They had a Moderna Bivalent booster for adults on one storage box, and a Pfizer.  Knowing the Modern, having prepped it, drawn it, and administered it multiple times a day at my own clinic, was not the correct one.  I grabbed the Pfizer and read the bottle, I saw Pfizer, 5-11 years old and since drawing myself the 10 doses of 0.2 mls, completely missing the very small Bivalent.  I finally found another MA who showed me where the correct syringes were, and I mentioned it was a 0.2 ml does instead of the 0.25 ml dose.  I didn?t have the Covid vaccine sheet explaining Pfizer and Moderna rules and descriptions of bottes, for me to double check myself.  Trusting what I read in the rush and the MAs who set me up, I drew up the 0.2 ml dose and went to MA and appeared to be MA in charge while the Medical Support Supervisor was out, to verify all the vaccines since she was the one to pull the Pfizer out of the fridge.  At that time none of the Mas had prepped the charts to see what is needed and what vaccine the child was to receive or has had.  MA signed my double check vaccine forms, and I went and administered them.  When I got back and started documenting the vaccines and locations, I noticed they didn?t have the expiration written on the box or bottle, so I went to MA and asked about it.  I asked what the expiration date was as the bottle stated 8/22.  She grabbed her spiral notebook with dates and pointed to the Pfizer booster expiration date.  I corrected her stating this was a Primary dose.  She got up and took me to the lab an pulled the box from the freezer and showing me the expiration date.  I again repeated Primary dose.  At that point she told me she failed me due to pulling the wrong thing and then signing it off.  I asked what we were supposed to do, and she told me the patient needed to be contacted.  She told me she would take care of things, but when I contacted her a day and a half later, neither the patient nor the provider was notified.  I am reporting at my soonest availability.  I did communicate with my MSS and was given the workflow to report the error.
Prior to receiving dose of the Janssen Cov-19 vaccine, the patient expressed that he had a fear of needles. The vaccine was admistered and the patient was asked to stay seated in the waiting area after the injection. After a few minutes the patient passed out while seated and was moved to being seated on the floor by staff. The patient was given water and his blood pressure was monitored periodically for the next hour before releasing the patient.
Fever highest 101.6   Chills Body aches Exhaustion Treated with extra strength Tylenol  And sleep Woke up today with the ?day after the flu? residual malaise
Bruising at injection site, redness around injection site. Sore arm some swelling and itching
Case number PHEH2014US020236 is an initial spontaneous report from a health care professional (patient) received on 01 Oct 2014. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. Her vaccination history included administration of three doses of FLUVIRIN (batch numbers: not reported) in the previous years following which her arm was swollen, red and hot (see related case numbers: PHEH2014US020232, PHEH2014US020234 and PHEH2014US020235). She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date, after vaccination her arm was swollen, red and hot .The outcome of the events was not reported. The patient received FLUVIRIN for the next 4 years and experienced similar events (see related case numbers: PHEH2014US020237, PHEH2014US020238, PHEH2014US020239 and PHEH2014US020240).
Menstrual cycle changes, heavier and longer days for Menstrual flow. Delayed time between cycles. From a 28 day to 34 days in length, and from 6 days to 9 days of actual menstration.
Macular degeneration; I had little spurts of turquoise and a dark shade of yellow; A spontaneous report was received from a Consumer concerning a 88-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events macular degeneration, everything was a beautiful shade of turquoise, it lasted about an hour, an hour and a half, and then dissipated, i had little spurts of turquoise and a dark shade of yellow.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the events everything was a beautiful shade of turquoise. it lasted about an hour, an hour and a half, and then dissipated. On 31 Jan 2021, the patient experienced the events macular degeneration and i had little spurts of turquoise and a dark shade of yellow.  Treatment details included Not provided  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, everything was a beautiful shade of turquoise, it lasted about an hour, an hour and a half, and then dissipated, macular degeneration, i had little spurts of turquoise and a dark shade of yellow was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fatigue, abnormally sore throughout body, lymphnodes swollen near injection site: under left arm and near left collar bone. Soreness subsided after 3 or 4 days but lymph's stayed swollen for 3 weeks. Tender to touch.
Swollen upper lip for two days starting the day after booster shot.  Also, sometimes in the evening, I break out in hives.  I do not have a medical history of hives prior to receiving booster shot.  I did not break out in hives from the first two Pfizer shots either.  Two months after, I still break out into hives once in a while.
has a high temperature; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced high temperature, running a temperature of 103.3. Consumer stated that patient wasn't able to get treatment recommendations for fever from the company that manufactures the vaccine. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt was given MMR II on 9/1/2023 and then given Varivax on 9/5/2023 = we were not informed of the MMR until after Varivax was given.
Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   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 received as follows: The age at vaccination was not applicable for this report. The patient was unable to obtain a second dose until at the time of reporting. How effective would a second dose be now since it is over a year since my first dose, which led to incomplete course of vaccination.
Narrative:  72yo male patient pt died at home in home hospice care on 1/31/2022 from Metastatic Head/Neck Cancer . Pt had received covid vaccines on 1/25/21, 2/22/21, 11/15/21. This death is not related to the covid vaccines.
Patient received partial dose of the vaccine as significant portion of the vaccine leaked out between the hub of the needle and the syringe.
Said she passed out twice in succession to each other. In about a 5 minute period of each other. Now, if feeling normal after 24 hour mark is past
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and injection site rash. SHINGRIX was discontinued. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the injection site rash was recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site rash to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported but it could be between 50 and 64 years. The patient was called by the office to receive the 2nd dose of SHINGRIX vaccine. But the patient refused and stated that, after her 1st dose of SHINGRIX, she had pain at the injection site with a rash that went from injection site all the way to hand. The reporting nurse asked if the patient sought any medical treatment for rash. The patient said she did not and the rash lasted for 3 weeks. The reporter did not agree to follow up from GlaxoSmithKline (GSK).
12/5/21 pt to ED due to husband not being able to awaken her; evidence of UTI in ED; positive COVID test in ED; O2 supplementation, 1 L via NC; admitted for UTI and altered mental state; started on ABX, Vitamin D, dexamethasone; DNR/DNI; husband desires to take pt home; dc'd to home 12/8/21, where pt passed away
On 11/24/2021 the above pt. was at center for shortness of breath. According to the documentation for the hospital she was given the vaccines listed above. She had previously received the Pfizer COVID19 vaccine on 12/31/20, 1/21/21 & 10/4/2021 and the Influenza vaccine also on 10/4/2021 while at the home. This information was sent with her to the hospital on 11/23/21. She returned to our facility on 11/24/2021 after 3pm. No adverse effects were observed upon her reurn and upon reviewing her medical records for 11/23/21 to 11/24/21  a medication record was observed with the documentaion of the vaccines given.
raised welts across Trunk, arms, thighs, really anywhere.  ice pack  for a few weeks  Then returned briefly for a week or two a month later  As of two weeks ago August into September has started back worse than before still ongoing.     Have photos of said marks/welts
vial was initially stored in the refrigerator 14 Nov 2022, vial was first punctured 19 Nov 2022, Stored post puncture in Room temperature; No adverse event; A couple of patients got a dose from a vial that had been punctured & was beyond 12 hrs.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A couple of patients got a dose from a vial that had been punctured & was beyond 12 hrs.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 14 Nov 2022, vial was first punctured 19 Nov 2022, Stored post puncture in Room temperature) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Nov-2022, 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 20-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A couple of patients got a dose from a vial that had been punctured & was beyond 12 hrs.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 14 Nov 2022, vial was first punctured 19 Nov 2022, Stored post puncture in Room temperature) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A couple of patients got a dose from a vial that had been punctured & was beyond 12 hrs.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 14 Nov 2022, vial was first punctured 19 Nov 2022, Stored post puncture in Room temperature) 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 (A couple of patients got a dose from a vial that had been punctured & was beyond 12 hrs.) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 14 Nov 2022, vial was first punctured 19 Nov 2022, Stored post puncture in Room temperature).    No concomitant medications was reported.  The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 14-Nov-2022. The vial was first punctured on 19-Nov-2022. Exact time of puncture was unknown. The vial was stored in room temperature post puncture. The vial does not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range was Afternoon/evening time. It was used at 10a.  No treatment medications was reported.
was believed that patient received a second dose; patient received a 2nd dose of Kinrix at 21 months; patient 19 months and 16 days old, received a dose of Kinrix; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 19-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 16th December 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 16th December 2021, not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device and unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 23rd February 2022, the patient experienced extra dose administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the extra dose administered, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-Apr-2022 Reporter's Comments: The reporter stated that a 19 months and 16 days old patient received 1st dose Kinrix, it was believed that patient received a second dose of Kinrix as well. No prior immunization was confirmed. The reporter did not consent to follow-up.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The 19 months and 16 days old patient received 1st dose of Kinrix, which led to inappropriate age at vaccine administration. The patient also received 2nd dose of Kinrix at 21 months of age, which led to inappropriate age at vaccine administration and extra dose administered.
Chills; Fever; Headache; muscle pain; Joint pain; This is a spontaneous report from contactable 70-year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EWU153) via an unspecified route of administration on 14Apr2021 at 1300 hours (70-year-old) on left arm, as dose 2, single for COVID-19 immunization. Prior Vaccinations (within 4 weeks) Iwithin four weeks prior to the first administration date of the suspect vaccine, events following prior vaccinations, patient's medical history, family medical history relevant to event, relevant tests, additional vaccines administered on same date of the pfizer suspect were reported as none. No investigation assessment was done. The patient's concomitant medications were not reported. The patient previously received the first received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date (70-year-old) as dose 1, single for COVID-19 immunization. On 14 Apr2021 at 22:00 hours the patient had chills, fever, headache, muscle pain and joint pain. She wanted to know if it was okay to take Tylenol or Aleve for her symptoms. Treatment was reported as none. The patient did not require emergency room and physician office visit. The event chills, muscle and joint pain were ongoing. On 15 Apr2021 headache recovered. On 16 Apr2021 fever recovered. PSCC Communication: Advised caller that they may speak with Medical Information and they may be able to provide them with medical information based on literature from research or studies. They cannot provide recommendations. They may refer them to the healthcare provider that is medically overseeing them. Caller declined transfer.   No follow-up attempts were needed. No further information was expected.
Member received smallpox vaccine and had an allergic reaction by breaking out with small pimple like rash.
About 3 days after the 2nd vaccine my left arm(site of injection) became red again and slightly itchy. On that night my abdomen became very itchy and the following day it happened again. I recently had surgery and thought maybe it was a reaction to the surgery but the surgery was 4 weeks ago. Tuesday the itchiness spread to different body areas and hives and small red areas and welts began. Today I am itchy, and red on my chest, abdomen, and behind my knees. My old tattoos that are over 10 years old are raised amd bumpy and itchy. The symptoms of itchiness are greatest at night. They are also relieved with topical cortisone cream. The left arm has since stopped hurting. Other than surgery 4 weeks ago nothing has changed.
Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA (Redness). At the time of the report, ERYTHEMA (Redness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided.   Reporter did not allow further contact
On 09/14/2021 I started having double vision and on 09/17/2021 I had a stroke. I still have the double vision and my face is still droopy
Directly following SQ administration patient felt woozy, shaky and head spinning also mentioned tongue tingling, all dissipated within minutes.  Spoke with patient about 2 hours after event and she still felt weak and not good overall but no other symptoms reported at the time.
Info has been received from a licensed practical nurse concerning a 40 year-old male volunteer firefighter with no known drug allergies and no known medical conditions who on 12/02/2002 at 19:00 was vaccinated intramuscularly in the deltoid with a first dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). There was no illness at the time of vaccination and no symptoms following prior vaccination with the pt or his siblings. Concomitant therapy on 12/02/2002 at 19:00 included an intramuscular dose in the "opposite deltoid" of influenza virus vaccine (FLUZONE) (Batch #U0925AA). Both doses were "given with a 25 guage, 1" needle". It was noted that 2 hours after the vaccine was given he spent 20 hours at a fire scene and was engaged at times in "heavy physical labor". On 12/03/2002 at 21:00, the pt developed swelling, pain, erythema and "induration from elbow to shoulder". The duration was 1 week and he did not require medical care as a result of this. It was also noted that the nurse had suspected that this "activity played a major role in their reactions". The pt recovered on 12/09/2002. The nurse also reported on 9 other pts that were vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M) and developed induration (WAES #0212USA01192, 0212USA01193, 0212USA00729, 0212USA00825, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081). No further info is expected.