chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Vomiting; Headache; Fatigue; Heart is counting very fast; I don't feel well; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable female consumer (patient) reported that. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient took the first dose on 13Feb2021 which was last Saturday, and she experienced reaction like nausea, vomiting, headache, fatigue, her heart was counting very fast and she did not feeling well on unspecified day. Outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
ED with n/v/diarrhea; CT + Covid PNA; no supplement O2 needed; also dx with acute cystitis and mesenteric adenitis (tx with ab's); Labs: D-dimer 0.94 (peak) K+ 2.5 with admit;      Meds: merrem, zosyn, vancomycin, Tessalon Perles, florastor (probiotic), zinc; Also rec'd K+ for hypokalemia; symptoms much improved upon discharge and back to baseline
Began 10 hours after his vaccination he began to experience chills. 24 hours after his vaccination he had serious swelling in his left eye. Headaches and additional swelling under his left arm pit.
INCORRECT PRODUCT STORAGE; PATIENT RECEIVED PRODUCT THAT WAS EXPOSED TO MULTIPLE TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex.  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 not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 17-FEB-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 17-FEB-2022, the patient experienced patient received product that was exposed to multiple temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received product that was exposed to multiple temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649137, 20220649884, 20220649626, 20220649803, 20220649915 and 20220649370.
This report was received from Pfizer and was assigned manufacturer report number 2013214296 for PNEUMOVAX23. Nurse refers to an adult patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23, (lot number and expiration date unknown), dose number, dose, route and anatomical location unspecified. Concomitant medications were not reported. On an unknown date the patient experienced a local reaction to PNEUMOVAX23. The outcome of local reaction to PNEUMOVAX23 was unknown. The original reporter was a nurse. Additional information has been requested.
The little finger in the left hand was paralyzed with a tingling sensation and difficulty to move it.; The little finger in the left hand was paralyzed with a tingling sensation and difficulty to move it.; The little finger in the left hand was paralyzed with a tingling sensation and difficulty to move it.; Joint pain was a little bit stronger/joint pain in knees and a little bit in elbows; This is a spontaneous report from a contactable consumer. A female patient reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EE0175, Expiry Date and NDC number: not provided), via an unspecified route of administration on 01May2021 as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737,), via an unspecified route of administration on 03Apr2021 as 1ST DOSE, SINGLE for covid-19 immunization. The consumer stated that after the first dose she experienced chills and little bit of a runny nose. Later she experienced joint pain in knees and little bit in elbows. Consumer reported that, after second dose, she had stronger joint pain and left pinky finger paralyzed, with tingling sensation and difficulty moving it. The outcome of all events was unknown.   Follow-up attempts are completed. No further information is expected.
numbness, tingling, burning, itching, and coldness in her hands, palms, abdomen, and in her back; numbness, tingling, burning, itching, and coldness in her hands, palms, abdomen, and in her back; numbness, tingling, burning, itching, and coldness in her hands, palms, abdomen, and in her back; numbness, tingling, burning, itching, and coldness in her hands, palms, abdomen, and in her back; numbness, tingling, burning, itching, and coldness in her hands, palms, abdomen, and in her back; This is a spontaneous report from a non-contactable consumer (patient herself).   A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unknown date, the patient experienced numbness, tingling, burning, itching, and coldness in her hands, palms, abdomen, and in her back. She wants to know if these side effects have been reported with the use of the vaccine. The outcome of the events was unknown.
Patient felt a tingling sensation move up her body. Felt "weird". Lightheaded. BP approximately 20 min after shot 129/92; 20 min later 138/85; 20 min later 131/85. Feeling would stop, then recur x 3. Called patient 2 hrs later and he was back to normal. Patient also very stressed due to upcoming trip.
Stuffy ear the following day. Ringing would occur when sounds were heard like people talking, anything. Ear cleared up two days after the shot.
Infection; This non-serious case was reported by a consumer via call center representative and described the occurrence of infection in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 22m3k, expiry date 04-AUG-2024) for prophylaxis.  On 24-MAY-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 26-MAY-2023, 2 days after receiving Shingrix, the patient experienced infection (Verbatim: Infection). The outcome of the infection was resolving.  It was unknown if the reporter considered the infection to be related to Shingrix.  It was unknown if the company considered the infection to be related to Shingrix.  Additional Information: GSK Receipt Date: 01-JUN-2023 The Healthcare Professional (HCP) reported that, Shingrix was administered Intramuscular (IM) slightly below deltoid but believes it may had still been in deltoid muscle. On 26-MAY-2023, he developed Infection and he went to prompt care to be seen. HCP reported that, she texted patient on One day prior of reporting (30-MAY-2023) and he stated that he was much better. The reporter consented to follow-up.
PATIENT REPORTED HER LEFT ARM FELT TINGLY A FEW MINUTES AFTER VACCINATION. SHE THEN FELT LIGHT HEADED AND SHE SAID WAS NOT SURE IF SHE WOULD PASS OUT. SHE ALSO FEALT LIKE SHE MIGHT VOMIT. PATIENT SAT WITH HER HEAD ON THE TABLE AND RESTED. THE PHARMACY PROVIDED HER WITH WATER AND SOMETHING TO EAT. SHE DRANK SOME WATER AND ATE A LITTLE BIT. AFTER 20 MINUTES OR SO SHE FELT BETTER. AFTER 30 OR  MORE MINUTES HE HUSBAND CAME TO TAKE  HER HOME.
Arm below injection site is red and inflamed. It is hard to the touch, sore and swollen.
Patient received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number A54M3, expiry date 11th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th June 2021) and Shingrix (received 2nd dose on 16th September 2021).   On 10th February 2022, the patient received the 3rd dose of Shingrix. On 10th February 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
the vial adapter and the syringe adapter, were not connected to the syringe, so when caller picked up the vaccine the stopper on the syringe stayed in the box and fell off syringe right away; Vaccine poured out all over caller; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26-year-old male patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5023, Expiration Date: Feb2025) to be used for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious) with onset 08Oct2023, described as "Vaccine poured out all over caller"; DEVICE ISSUE (non-serious) with onset 08Oct2023, described as "the vial adapter and the syringe adapter, were not connected to the syringe, so when caller picked up the vaccine the stopper on the syringe stayed in the box and fell off syringe right away".   Causality for "the vial adapter and the syringe adapter, were not connected to the syringe, so when caller picked up the vaccine the stopper on the syringe stayed in the box and fell off syringe right away" and "vaccine poured out all over caller" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: Reporter was a pharmacy technician calling about Abrysvo which he was going to administer yesterday however, the product was broken before he even took it out of the box. The product was in the actual Abrysvo manufacturer box, the individual Abrysvo. He stated that "the little things you open up to compound the vaccine, the vial adapter and the syringe adapter, were not connected to the syringe, so when caller picked up the vaccine the stopper on the syringe stayed in the box and fell off syringe right away. Faulty product." Vaccine poured out all over caller. He confirmed no patients were involved, however since he stated the vaccine poured out all over him, his information was placed in patient formal fields. He was wondering if it was possible to get a replacement. Sample of the product was available to be returned, if requested; they can return the vial adapter. Packaging was sealed and intact. NDC number of Abrysvo: 00069034405; of Abrysvo antigen vial: 0069020701.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
On Friday 11/9/2018 as part of an employee vaccination clinic I received the flu shot, FLUZONE 0.5 mL at about 7:40 am; by10:30, 3 hours later, I could tell I wasn't feeling well at all. I left work at noon because of extreme fatigue, I went home and fell asleep immediately as I felt utterly exhausted. I woke 3 hours later feeling much worse with headache, all my joints ached, felt like I had a slight fever and still utterly fatigued. My symptoms did not get better that evening and I went to bed around 8 p.m., woke around 2 a.m. feeling awful still but managed to get back to sleep eventually. When I woke Saturday 11/10/2018 morning, I felt slightly better, fever was gone, headache gone but joints still ached and still really fatigued. I took a long nap that afternoon, woke feeling slightly better but still was in bed sleeping by 9 pm because I was so tired. Sunday, 11/11/2018, I woke feeling better, 80% of the ache in my joints was gone, and only about half as fatigued; I took a long nap again that afternoon, and was again in bed by 9 pm because I was so tired. This morning, Monday 11/12/2018, I feel somewhat fatigued and the only joints that ache are in my fingers and wrist.
Around 4AM this morning I woke up and felt fatigued and was warm to the touch. I tried to go to work but had to come home. When I got home my temperature 100.1, I have nausea, body aches, chills. I have been coughing as well.  I contacted my primary care, they recommended to treat the symptoms and it should go away in a day or two.
This spontaneous report as received from a 16 years old female patient. The patient was vaccinated with GARDASIL in APR-2012. No other co-suspects were reported. Concomitant medications included unspecified medications for "ADHD" and "Birth control". In APR-2012 the patient experienced pain in arm. No treatment information was reported. The outcome of pain was reported as recovering/resolving. Pain in arm is related to GARDASIL.
Patient states that after she received her first covid vaccine, her WBC and RBC went out of range. She stated that she had blood coming out of her nose and eyes and was admitted to the hospital and was in the ICU for 3 days. During that time she had about 8 blood transfusions. She also reports having itchy rashes on her body and blisters inside her mouth that were very bothersome. She states that she's out of the hospital now and is doing better but feels like her body is still fighting off a cold.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Additional Details: blueish right calf
Patient immediately passed out and turned pale upon receiving vaccination. He came back within a minute, was checked out by paramedics and went home.
Night after vaccine (4/30/2021 to 5/1/2021): had trouble sleeping despite being tired (atypical for me), felt overly warm (atypical for me) 5/1/2021, 8am: woke up feeling disoriented, fell back asleep 5/1/2021, 11:30am: woke up and could not fall back asleep, even though I still felt tired. Felt very overheated, had migraine headache, felt sore in hips, knees, and neck. Treated migraine with 2 tablets of 220mg naproxen sodium. Fell back asleep around 12:15pm and slept till 2:30pm. Felt better when I woke up.  5/1/2021, 6:00pm: headache returned, felt drowsy. Napped for approximately 1hr 45min. Woke up and headache was still bothersome. Took 2 more tablets of 220mg naproxen sodium. Headache faded.  5/2/2021: mild headache and soreness persisted on and off until the evening.
This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 07-JAN-2015, the patient was vaccinated with a dose of M-M-R II, (strength, dose, route and anatomical location were not reported), (lot # J006995, expiration date: 14-JUN-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Redness, swelling, and induration over the left deltoid area where the vaccine was administered.
Covid Arm. Silver dollar size red mark still on injection site with minimal swelling very little itching still at this date. Can feel lump under surface about size of tennis ball flat.
Patient presented for a flu vaccination at our mobile clinic. Upon billing the claim, we discovered patient had already received their flu vaccine on 9/6/22. On 2/1/23, s/w nurse at the facility who stated she would notify us with any issues. Unable to contact patient directly.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My arm swelled up), LIMB MASS (I had a golf ball size knot), PRURITUS (My arm was itching for about 9 days), PAPULE (I got water pumps on the arm that I received the shot in / Water pumps on the arm) and VACCINATION SITE ERYTHEMA (My arm was red for about 9 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (My arm swelled up), LIMB MASS (I had a golf ball size knot), PRURITUS (My arm was itching for about 9 days), PAPULE (I got water pumps on the arm that I received the shot in / Water pumps on the arm) and VACCINATION SITE ERYTHEMA (My arm was red for about 9 days). At the time of the report, PERIPHERAL SWELLING (My arm swelled up), LIMB MASS (I had a golf ball size knot), PRURITUS (My arm was itching for about 9 days), PAPULE (I got water pumps on the arm that I received the shot in / Water pumps on the arm) and VACCINATION SITE ERYTHEMA (My arm was red for about 9 days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient stated that - Patient got water pumps on the arm that I received the shot in No concomitant medications provided. No treatment medications provided.
A little headache; A achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "A little headache", "A achy"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "A little headache", "A achy". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "A little headache"; PAIN (non-serious), outcome "unknown", described as "A achy".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt states that she developed a 4" red, itchy rash around injection site along w/ a headache that lasted about 3 days. pt took tylenol for pain.
This spontaneous report as received from Licensed Practical Nurse refers to a patient of unknown age and gender. Information on patient's medical history and concurrent condition was not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # L027726, expiry date 10-MAY-2017. It was reported that the temperature excursion call was because of usage of data logger. Temperature excursion was 32 F. Time frame: 15 hours. There was no previous excursion reported. No adverse effects reported. No further information was provided. Additional information has been requested.
Patient was given 2 Flucelvax influenza vaccinations at the pharmacy on 10/28/2022.
did not receive the second dose of the vaccine for 2 months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive the second dose of the vaccine for 2 months) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive the second dose of the vaccine for 2 months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive the second dose of the vaccine for 2 months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.
For this member age, the OLD workflow was 3 Monovalent Moderna vaccines (primary dose) followed by a BIVALNT dose (2 months after completion of primary dose).  The NEW workflow is 2 Monovalent Vaccines followed by a BIVALENT dose (2 months after completion of primary dose).  The nurse worked in the clinic on this day and was following the old workflow of the vaccine schedule.    Every toddler has to be observed for 15 minutes after the vaccines, no reaction reported by parents or staff.
Pt recvd 5 doses of Engerix-B & Antibodies were checked 4-6 months p/3rd dose & there was no antibody; 4th dose was given AUG90 & antibodies were still neg; 5th dose was given 05MAR91;
No adverse event; patient received 2 Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received 2 Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an 88-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 043H22A and 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Mar-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (patient received 2 Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (patient received 2 Bivalent Moderna COVID-19 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 EXTRA DOSE ADMINISTERED (patient received 2 Bivalent Moderna COVID-19 vaccine).    On 01-FEB-2021, patient received first Primary monovalent dose (Lot 042L20A and Exp. Date: 05-JUL-2021).  On 01-MAR-2021, patient received 2nd Primary monovalent dose (Lot 022M20A and Exp. Date: 08-AUG-2021). On 15-APR-2022, patient received First Monovalent Booster dose (Lot 065K21A and  Exp. Date: 05-JUL-2022). Dosage text of fifth dose was reported as additional booster.  No concomitant medications was reported.  Patient received bivalent vaccine in a shortened suggested time frame.  No treatment medications was reported.
Decreased appetite/refusal to nurse. Respiratory issues. Loss of interest in normal activities. Agitation. Developed in 24hrs following vaccines.