chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Products liability: manufacturing defect/defective design; Information has been received regarding a case in litigation from a lawyer and refers to a currently 71-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On approximately 17-JAN-2013 (reported as on or about 17-JAN-2013), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (strength, dose, route of administration, lot number and expiry date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by the physician due to the event. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided.  The reporter consider the event of shingles to be related to the  suspected vaccine.  The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
I also starting coughing last night; Swelling of lips; tongue is swollen; Tingling tongue and lips; redness around her lips and tongue; redness around her lips and tongue; my throat is sore; my throat is sore, itchy and force like I am talking for the long time and I feel force; My throat is tired you know when you are taking for long time and you cant talk/ I  feel force; This is a spontaneous report received from a Pfizer Sponsored program. A contactable female consumer (patient) of an unspecified age reported that she received bnt162b2 (BNT162B2 Solution for injection), dose 2 via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced i also starting coughing last night on 25Jun2021, swelling of lips, tongue is swollen, tingling tongue and lips, redness around her lips and tongue, my throat is sore and  my throat is sore, itchy and force like i am talking for the long time and i feel force and my throat is tired you know when you are taking for long time and you cant talk/ i  feel force on Jun2021. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
10min after being given the shot, I had my throat closing sensation. There were no hives or rash, just the throat sensation. I took a Zyrtec and then reaction started to reduce 20-25min from having taken the pill. 10 hours since the reaction, I felt my lip starting to swell, at which time I took a Benadryl. Next morning almost 20 hours since the reaction, I had another throat closing episode with another snack that I am regularly used to eating. Hopefully this is the preliminary vaccine reaction and not a permanent change! I already have other food/drug allergies, but had no effects with the first 3 doses of Pfizer taken in March 21, Dec. 21 of last year.
Lot # had extended expiration date and vaccine had remained frozen until date of administration but was given 2 days past expiration date.  Moderna consulted and deemed the vaccine viable so revaccination was not necessary.  No adverse side effects were reported from patient.
at the area of the injection, it is red, hot, warm to touch, about the size of an egg and kinda hard to touch; at the area of the injection, it is red, hot, warm to touch, about the size of an egg and kinda hard to touch; at the area of the injection, it is red, hot, warm to touch, about the size of an egg and kinda hard to touch; This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for a 93-Year-Old male patient (father) that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller stated that her 93-year-old father got the first Pfizer vaccine on 29Jan2021. He didn't say anything about it until yesterday but "at the area of the injection, it is red, hot, warm to touch, about the size of an egg and kinda hard to touch". "It seems to be redder today. What does she do. The outcome of the event vaccination site erythema was reported as not recovered. and outcome of other events was unknown.  Information regarding batch/lot has been requested.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Dulled hearing in right ear progressed to tinnitus in both ears over the 4 weeks between shots.
Headache, weakness, local redness/edema/mass/pain and rhinorrhea.
p/vax pt exp seizures for one minute; also exp fine rash from head to toe & purple discoloration surrounding eyes; rash was tx w/diphenhydramine; no fever noted;sz considered an other medical event;
low grade fever; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), MYALGIA (body aches) and FATIGUE (fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergy to Sween Cream) and Penicillin allergy. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE) for Blood pressure, PRAVASTATIN SODIUM (PRAVACHOL) for Cholesterol, LEVOTHYROXINE SODIUM (LEVOXYL) for Hypothyroidism, ACETYLSALICYLIC ACID (BABY ASPIRIN) from April 2020 to an unknown date, VITAMIN D3 from March 2020 to an unknown date and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 02-Feb-2021 at 11:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (low grade fever), MYALGIA (body aches) and FATIGUE (fatigue). On 04-Feb-2021, PYREXIA (low grade fever) and MYALGIA (body aches) had resolved. At the time of the report, FATIGUE (fatigue) outcome was unknown.            No treatment details were added. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-013132 (Patient Link).
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who received 0.5 mL dose of vaccines PENTACEL lot C5517AA in the left thigh (Lot Lyophilized powder vial lot C5517AA expiry date: 9/15/2019, Liquid vial Lot C5422AA NDC expiry date 9/15/2019) (route not reported) on 08-Oct-2018. Patient also received vaccines ACTHIB lot UI907AA in the left thigh (Lot for ACTHIB: Liquid U6047AA expiry date: 10/24/2019, Powder UI907AA, expiry date: 10/26/2019) (route and dose not reported) on 08-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; and ROTATEQ for Immunisation. It was an actual medication error due to extra dose administered. It was reported that gave a complete PENTACEL vaccine, both liquid and lyophilized powder vials reconstituted properly, and she also gave him a second dose of ACTHIB for a total or 2 HIB vaccines. No reaction reported. 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. Documents held by sender: none.
I had my vaccination on 09/23/2022. On 09/25/2022 the room started to move I got nauseated and threw up. It lasted for 24 hours. I didn't do anything except rest. I experienced the vertigo again when contracting COVID-19 on 11/27/2022.
THIS PATIENT HAS A SEIZURE DISORDER AND WAS MONITORED AFTER RECIEVING THE VACCINE. THIS PATIENT DOES LIVEIN A GROUP HOME AND IS MONITORED BY STAFF. THE STAFF EMAIED TO LET US KNOW THAT ONCE THE PATIENT GOT HOME HE DID HAVE "A RIDICULOUS AMOUNT OF SEIZURES TODAY."   THE GROUP HOME SPOKE TO THE DOCTOR AND TOOK A PREFILLED SYRINGE OF ATIVAN.
Headache,warm, after walking daily 2 miles ,Friday Morning,went home ,slept from noon till 5 p.m. headache disappeared. Today,walked 2 miles daily, had burrito,water for breakfast,came home began having bowel run-off.Unusual for an afternoon of staying in
"The morning after my COVID vaccine, I woke up with numbness, tingling, and pain in my R great toe.  The next 48 hours the symptoms got worse, and I had paresthesia in b/l upper and lower extremities, my trunk, and my face.   My symptoms resolved for 2 weeks, but returned on Jan 10th.  They started the same way with numbness and paresthesia in my R great toe and have progressed since them.  I'm currently have frequent episodes of paresthesia all over my body and have developed numbness and pain in my hands. I saw my primary physician on Jan 15th regarding the symptoms."
Client received 1st COVID vaccine of Pfizer (Lot# EW0185 expiration date 05/27/2021). Client reported lightheaded. EMT responded at 1521. RN notified and responded to this event. At 1521, vital signs are blood pressure 120/69, heart rate 69, oxygen saturation 97%. Client reports history of asthma, no current use of any medication, allergies to Keflex. Client reports he ate today and felt "nervous coming today". Client was offered supplemental nutrition and fluids. Client denied nutrition, but accepted fluids. At 1528, vital signs are blood pressure 125/74, heart rate 73, oxygen saturation 97%. Client states "tight throat", no shortness of breath, headache in the occipital area, no nausea, no chest pain. RN offered 50mg of Benadryl by mouth. Client denied. RN educated Client about ED precaution and common adverse effects of COVID vaccine. At 1532, vital signs are blood pressure 125/67, heart rate 71, oxygen saturation 98%. Client reports tightness in the throat is the same. RN offered 50mg of Benadryl by mouth and paramedic services. Client accepted 50mg of Benadryl by mouth, but denied paramedic services. RN advised Client that Benadryl will result in fatigue and drowsiness. Client states his mother is driving him home. At 1534, 50mg of Benadryl was administered by mouth. At 1535, Client reports the tightness in the throat is improving, no shortness of breath, no chest pain, no nausea. At 1538, vital signs are blood pressure 123/77, heart rate 81, oxygen saturation 97%. Client reports headache is improving, no shortness of breath, tightness in the throat is improving. Client is accompanied by grandmother and reports mother is driving them home. At 1544, vital signs are blood pressure 123/77, heart rate 82, oxygen saturation 97%. Client reports headache is present but improving, tightness in throat is improving, no blurred vision, no chest pain, no nausea. RN offered paramedic services in regards to the tightness of the throat, but Client denied offer. At 1550, Client stood up with no complaints. Client left facility with grandmother and picked up by mother at 1553. Client walked out with a steady gait.
After receiving varicella vaccine - felt feverish, fatigue, cold like symptoms with some shortness of breath. Approximately 10 days later (L) arm became swollen, red, sore to touch, "hard like a ball" and "skin was bubbly".
Patient was supposed to receive a first dose of the Pfizer COVID-19 vaccine primary series (monovalent), however, pharmacy staff inadvertently gave a dose of Pfizer Bivalent Booster vaccine.
Covid like symptoms; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced covid like symptoms and tested positive for covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, 13 days prior to the onset of the event covid like symptoms, the patient received their first of two planned doses of mRNA-1273 (032L20A) in the left arm for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced covid like symptoms.  On 01 Feb 2021, the patient tested positive for covid.  Treatment for the event included Tylenol.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the covid like symptoms and tested positive for covid was not recovered (ongoing).; Reporter's Comments: This case concerns a 73-year-old female who experienced a nonserious unexpected event of COVID-19.  The event occurred 13 days after the first dose of mRNA-1273. Treatment included Tylenol. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Headache, Arthralgia, Fever, Angina, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, CHEST PAIN Narrative:  She was hospitalized on 1/24/2021 in the AM D/C home 1/25/2021 PM for abnormal EKG. She is set up for a stress ECHO with plans follow up with PCP on 2/1/2021. She is fatigued and has headache, chest pain that is stabbing in nature has improved. She has SARS-CoV-2 test pending. CRNP She plans on returning to duty tomorrow at 0730. She is going to bring her work restriction note from her PCP. She has been directed to report to employee health for return duty evaluation CRNP 2/2/2021
Right arm deltoid muscle swollen and red, noted by parent 2 days after vaccination. Applied ice to sight.
My arm is swelling, painful, and hurts at touch; My arm is swelling, painful, and hurts at touch; Every time I lift my arm I get a severe pain; I have shooting pain; it is itchy and the red mark is getting bigger and bigger; it is itchy and the red mark is getting bigger and bigger; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot Number/Expiration date: not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. Relevant medical history and concomitant medication were not provided. On an unknown date, the consumer stated that "my arm is swelling, painful, and hurts at touch and every time I lift my arm, I get a severe pain and it is itchy and the red mark is getting bigger and bigger. Every time I lift my arm I have shooting pain". The outcome of the events arm is swelling, painful, and hurts at touch, shooting pain and it is itchy and the red mark is getting bigger and bigger was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
FORGOT TO TAKE LAST DOSE; This spontaneous case report (PVX2019-2513) was received from a consumer on 08-Oct-2019. It described a female consumer who "forgot to take last dose" (PT: Product dose omission), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took first three doses of Vivotif, but forgot to take the fourth dose, which was due on 07-Oct-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "forgot to take last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take last dose" was considered as not applicable.
Fatigue, headache, nausea -- roughly 24 hrs. Extreme kidney pain (10) -- roughly 14 hrs.
4-2-21 1:15PM TC: PT STATES SHE HAS A RASH TO RT ARM AT THE INJECTION SITE. NO SOB, NO PAIN, NO DIFFICULTY SWALLOWING. NO ACUTE DISTRESS.
7-10 days after injection, at site of VARIVAX vaccine, red, hard, tender lumps had developed.
report after his booster dose of the Moderna COVID-19 vaccine he started to experience tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (report after his booster dose of the Moderna COVID-19 vaccine he started to experience tinnitus) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (report after his booster dose of the Moderna COVID-19 vaccine he started to experience tinnitus). At the time of the report, TINNITUS (report after his booster dose of the Moderna COVID-19 vaccine he started to experience tinnitus) outcome was unknown.            No concomitant medications reported. No treatment reported.   This case was linked to MOD-2022-531762, MOD-2022-531761 (Patient Link).
no adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated- wrong vaccine; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated- wrong vaccine) and NO ADVERSE EVENT (no adverse event) in a 7-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and AS7647B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 18-Jul-2023, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 25 microgram. On 21-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated- wrong vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated- wrong vaccine) 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 (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated- wrong vaccine).    Concomitant medication was not reported.  Dose 1 of Monovalent vaccine was given on 19-APR-2023 of dosage (25 microgram) and batch number ASI903B.  The route of administration of suspect Moderna bivalent dose 2 and 3 was reported as BI.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Received vaccine on 3/3/21 at 2:30pm. Waited for 20 minutes at pharmacy for allergic reaction. Given the all clear, so headed home. Around 5pm, I started noticing how extremely sore my left arm was, almost as if somebody had hit it with a baseball bat (no bruising, redness, etc., just VERY sore). I also started noticing numbness and tingling in my left arm that traveled down the outside of my arm into my left hand and into my left pinky finger.   As the evening progressed, I lost my appetite, developed a headache, felt extremely fatigued, was dizzy, had muscle and joint aches, had left kidney pain, and began to feel flushed and hot. I took my temperature and it showed I was running a low-grade fever of 98.7F (my normal temperature is anywhere between 96.9F and 97.1F). I went to bed around 9pm.  Around 3am (which is now 3/4/21), I woke up with nausea, and my left arm/hand/finger really experiencing numbness and tingling (it's as if that portion of my arm/hand/finger was semi-paralyzed). I went to the bathroom and was on the verge of throwing up. I broke out into a cold, clammy sweat but did not vomit. I got back into bed and went back to sleep.  Around 5am (still 3/4/21), I woke up again with nausea and my left arm/hand/finger still numb and tingling (semi-paralyzed). I went to the bathroom and was again on the verge of throwing up. I, again, broke out into a cold, clammy sweat but did not vomit. I got back into bed. I decided to take a Zofran around 6am for the nausea.  I slept from 8am-12pm on 3/4/21 due to the Zofran. When I woke up, I called the pharmacist at pharmacy to notify them of my symptoms. The pharmacist everything I experienced was normal and should go away in 2-3 days (if they didn't then contact my regular doctor), that I could take Tylenol for any pain, and I still needed to keep my follow-up appointment for the second shot.  The entire day on 3/4/21 from 12pm until I went to bed around 10pm, I still experienced an extremely sore arm, loss of appetite, slight headache, fatigue, dizziness, muscle and joint aches, left kidney pain, low-grade fever (for me), and the numbness/tingling/paralysis in my left hand and left pinky finger.  I was able to sleep through the night, and woke up around 6am on 3/5/21. Currently, I am still experiencing an extremely sore arm, fatigue, and the numbness/tingling/paralysis in my left hand and left pinky finger. I am EXTREMELY concerned about the numbness/tingling/paralysis in my left hand and left pinky finger as it does not seem to be getting better.
Due to inconsistency with the state reporting site, an extra dose with administered. Pt is immunocompromised and is needed to receive 3 primary series vaccines. Our chart showed 2 doses and due for a 3rd. The state database had multiple profiles with no information. Patient received a vaccine and when we were charting another profile was seen on the state database which showed the patient had already received 3 primary doses prior.