chrisvoncsefalvay/vaers-outcomes huggingface dataset:
terrible cough; She has inflammation of the bronchiol tubes; chronic asthma; This is a spontaneous report from a contactable consumer (patient) received via Pfizer Sponsored Program Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 09Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported that she developed a terrible cough 2 weeks after (Mar2021) getting first dose. She has chronic asthma, inflammation of the bronchial tubes (2021). She got some tests done, her lungs were clear and the oxygen in her blood was okay. She wanted to know if that was happening because of the vaccine. The patient underwent lab tests and procedures which included investigation: her lungs were clear and the oxygen in her blood was okay and oxygen saturation: oxygen in her blood was okay on an unspecified date in 2021. The clinical outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Two hours after receiving the flu vaccine the patient developed hives and fever of 102.00. The patient's mother gave her benedrayl and tylenol and then came to my office today. I performed an exam and the patient had hives around her mouth and eyes as well as the upper part of her neck. I prescibed hydroizine to the patient for the hives.
Nurse also reports she cut herself while cleaning out the box of MMR II; one vial is completely shattered; Nurse also reports she cut herself while cleaning out the box of MMR II; Nurse also reports she cut herself while cleaning out the box of MMR II; This spontaneous report was received from a female nurse of unknown age referring to herself.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 18-JAN-2023, the reporter discovered upon opening a box that the vial of started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) subcutaneous injection, lot #W009750, expiration date: 22-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided) was broken (product container issue). The vial was completely shattered and everything else was sticky. The lid was stuck to the bottom of the box. Nurse reported the affected product was not available for retrieval as it was completely shattered and has been discarded. On 18-JAN-2023, the reporter cut herself while cleaning out the box (skin laceration, accidental exposure to product, product package associated injury).  At the time of reporting, the outcome of the event was not known.  According to the question section: The damage was noted upon opening the carton. The damage affected the entire vial, everything was sticky. The vial was completely shattered into many pieces. There was a broken glass in the carton. The carton or label did not appear wet, just sticky. The carton or label appear to have been potentially wet in the past and dried. There was not any product remaining in the broken vial. The vial was from a multi-vial carton or tray (10x (ten-by) carton), the affected vial was second row far on the left. The vial's carton was not damaged upon receipt. The product was stored in its original carton after it was received. The shipping container/Styrofoam shipper was not damaged upon receipt. The product was not administered or exposed to patient's bodily fluids. The complaint sample cannot be returned as it has been discarded.   The reporter considered product package associated injury to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The causal relationship between skin laceration and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
2:00 AM - was covered in welts, skin was itchy. Went to the ER. Blood pressure was 160/102. Was covered in hives for 2 weeks. Took benadryl.
Reporter indicated that 28 pts recvd Engerix-B series; 8 pts have tested neg (3 pts tested pos p/1st booster dose, 1 pt borderline p/1st booster dose;
Soreness around site of shot that increased into moderate pain with mild swelling in upper arm and arm pit.  Slight swelling of under arm lymph node that has resided, but the soreness persists.
the patient receiving the injection was not injured/No further AE details; Registered Nurse called to report a PQC for GARDASIL 9. HCP reports that a Medical Assistant, who is a repeat device user was given a patient a GARDASIL 9 injection and was pushing the last bit of the dose into the patient when the barrel of the syri; Registered Nurse called to report a PQC for GARDASIL 9. HCP reports that a Medical Assistant, who is a repeat device user was given a patient a GARDASIL 9 injection and was pushing the last bit of the dose into the patient when the barrel of the syri; This spontaneous report was received from Other Health Professional and refers to a 27-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-AUG-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml/once, lot #W026151, expiration date: 20-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 16-AUG-2023, registered nurse called to report a PQC for GARDASIL 9. HCP reports that a Medical Assistant, who is a repeat device user was given a patient a GARDASIL 9 injection and was pushing the last bit of the dose into the patient when the barrel of the syringe shattered into multiple pieces. RN reports that the MA was injured and received a cut from one of the shattered pieces of glass on her right middle finger. RN reports that the MA was able to be treated with topical antibiotics and a band aide and did not require stitches. RN reports that the patient receiving the injection was not injured, and the full dose was given. PQC filed: 02453005 /No further AE details.
The dose was administered at 10 am on 3/13/21.  At approx 4 am 3/14/21  while using the bathroom I had an episode of severe dizziness and weakness that lasted about 15 minutes.  I did not pass out but did want to lie down.  I eventually was able to walk quickly to bed and lie down and fell asleep.  In the am when I awoke I felt ok, just a bit drained.
MMRII vaccine given IM instead of SUBQ. Informed patient of the mistake; should not have to repeat second dose per literature. Dose is still valid.
Swelling and redness at injection sites on left arm. Started 2 days after vaccines.
Patient received her first covid vaccine at approximately 9:05 am, walked over to the observation area and after sitting down reported to the post observation nurse that she felt dizzy and nauseous. Vital signs measured, wnl and pt. without s/s of anaphylaxis. She reports eating breakfast, history of motion sickness. She was helped to lie down and monitored for 25 minutes without incident. Water given. Dizziness/nausea slowly resolved. EMS offered, declined. Wheeled to car by staff and driven home by family member.
Normal swelling of Lymph Nodes under left injection arm 1 day post vaccine. Normal sore injection site. 2 Days post injection, I cannot lift my arm higher than about 45 degrees due to the shooting pain up my arm. My lymph nodes are EXTREMELY painful and swollen, the swelling and pain encompasses my left armpit, and my left lat muscle, my left chest near my arm, & my left deltoid muscle. The pain radiates up the left side of my neck as well as into my left elbow.. Depp, throbbing, painful type of  pain and Ibuprofen and Tylenol are not helping. I am reporting on day 2, if it does not ease up today I will go to the minute clinic tomorrow.
Yellow and purplish 2-3 inch brusing proximate to but not exactly at vaccination injection location
Swelling and rash on right arm where shots given started within 24 hours followed by severe symptoms of shingles: nerve pain, on right torso radiating from back to front followed by a rash on torso all within 3 days of receiving the vaccines.
fast heart beat; Chills; pain at injection site (left); fever; nausea; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, fast heart beat (atrial fibrillation ), fever, nausea, chills and was hospitalized with a diagnosis with atrial fibrillation.  The patient's medical history was not provided. Concomitant medications reported were Eliquis(apixaban) pill for drug use for unknown indication.  On 04-FEB-2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) Intramuscularly for prophylaxis of COVID-19 infection.   On 08-MAR-2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 003A21A) Intramuscularly for prophylaxis of COVID-19 infection.  On 08-MAR-2021, the patient experienced pain at injection site (left), fast heart beat, fever, nausea. On 09-MAR-2021, the patient experienced chills, The patient was diagnosed with atrial fibrillation and the patient was hospitalized on 09-MAR-2021 and discharged on 10-MAR-2021.   Treatment details not given but the patient was prescribed a Holter(14 days monitor).  Action taken with mRNA-1273 in response to the events was not applicable  The outcome of event(s), pain at injection site (left), fast heart beat, fever, nausea, chills, and atrial fibrillation was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  It is unclear if the patient had AFib before as she did not report prior medical history but is taking a medication usually prescribed for AFib. Further information has been requested.
pt dx w/mild case of GBS; Annual follow-up dated 10/12/00 provided no additional data.
VASOVAGAL: The patient stated she wasn't "feeling good," she felt very dizzy and temporarily lost vision, she was sweating as well. I immediately grabbed another chair and raised her feet above her heart level. She immediately stated that she was "feeling better" and started regaining her vision. we then offered her a cold bottle of water. She appeared very stable within a few minutes. We did call 911 as a precaution, they arrived a while later and deemed the patient was stable and their additional services were declined by the patient. I insisted the patient stay and finish the bottle of water. All together I believe the event was about 30 - 35 minutes before leaving. I encouraged the patient to drink plenty of fluids and electrolytes and to take it easy for the rest of the day.
Metallic taste within minutes of injection; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301358a) via an unspecified route of administration in the left arm on 11Sep2021 at 11:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. On 11Sep2021 at 11:45, within minutes of injection, the patient experienced metallic taste. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste within minutes of injection was resolving at the time of this report.
This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 2nd October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 1 day after receiving SHINGRIX, the patient experienced pruritus and red blotches. On an unknown date, the outcome of the pruritus was recovering/resolving and the outcome of the red blotches was recovered/resolved. It was unknown if the reporter considered the pruritus and red blotches to be related to SHINGRIX. Additional information was reported as follows: The patient received the vaccine in left arm. The next day following vaccination, the reporter began to experience itching on the upper part of her body for a whole month. After that it subsided a little, but the patient still had it six weeks after the vaccination. The itching started under her breasts and extended up to the sides of her neck. The patient had small red blotches on her upper chest which resolved after a couple of weeks. The itching had reduced in severity but had still not fully resolved at the time reporting. The patient enquired if the reaction experienced by her was normal or not, as it was not listed as one of the side effects. The patient also enquired whether the same thing would happen after vaccination with the second dose also and how long it would take to stop it altogether. The patient was told there are two types of vaccines, one with eggs as an ingredient and one without, where the person who told the patient had requested one without eggs and was given that one. The patient's pharmacist said that he didn't knew anything about this, that there was only one type with eggs. The patient requested to enlighten her on this and would much prefer not having eggs in her system. The reporter provided permission for her physician to be contacted but couldn't provide the name of physician because they had left the practice. Unable to obtain additional information.
I started having swollen lymph nodes under my arm pit. It comes and goes ever since I got my vaccine. I did talk to my doctor about it. I had blood work, my thyroid antibiotics was evaluated.
Tested COVID Positive Infected with Coronavirus; Tested COVID Positive Infected with Coronavirus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EP 6955), in left arm and on 08Apr2021 at 12:00 as dose 2, single (Lot number: EP 6955), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; TRICOR [FENOFIBRATE]; SINGULAIR; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant) with onset 27May2022, outcome "unknown", COVID-19 (medically significant) with onset 27May2022, outcome "not recovered" and all described as "Tested COVID Positive Infected with Coronavirus". On 23May2022 the patient also experienced generalized fatigue and cough as the symptoms of COVID-19. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Lipitor, Tricor, Singulair, Protonix and Lisinopril within 2 weeks of vaccination. The patient was infected with Coronavirus, severe symptoms lasting five days, generalized fatigue and cough continued. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 1 day after receiving BEXSERO, the patient experienced injection site pain, back pain and fever. On an unknown date, the outcome of the injection site pain, back pain and fever were unknown. It was unknown if the reporter considered the injection site pain, back pain and fever to be related to BEXSERO. Additional details were provided as follows: The age at the vaccination was not reported. The patient was administered BEXSERO in the arm. On an unknown date, the patient's body temperature was recorded as 101 degree F or so. The patient went to the hospital, but the reporter does not believe that they were hospitalized over night. The reporter has had frequent communication and follow-up with the patient.
A child with progressive muscle weakness in legs; admitted to the hospital on 4/19/02 due to tranient mild weaknes with some paraesthesias and arthalgias temporally related to a third hepatitis B vaccineation being possible causative. Per doc 214328, patient was hospitalized on 04/18/2002.
Felt like COVID 19 again; Aches especially on neck; slight swelling at injection site; Trrible headache; Fever of about 101; Aches especially on shoulder; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Felt like COVID 19 again), NECK PAIN (Aches especially on neck), VACCINATION SITE SWELLING (slight swelling at injection site), HEADACHE (Trrible headache) and PYREXIA (Fever of about 101) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Apr-2021, the patient experienced COVID-19 (Felt like COVID 19 again), NECK PAIN (Aches especially on neck), VACCINATION SITE SWELLING (slight swelling at injection site), HEADACHE (Trrible headache), PYREXIA (Fever of about 101) and ARTHRALGIA (Aches especially on shoulder). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COVID-19 (Felt like COVID 19 again), NECK PAIN (Aches especially on neck), VACCINATION SITE SWELLING (slight swelling at injection site), HEADACHE (Trrible headache), PYREXIA (Fever of about 101) and ARTHRALGIA (Aches especially on shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up received on 20-APR-2021. Reporter details was reported. Patient age was reported. Events was reported. Treatment medication was reported.
I experienced severe Tinnitus approximately two weeks after receiving the 2nd dosage of the vaccine (breaking glass and other noises) but I did not go to the doctor for the symptoms. The ENT sent me to another place for testing at a Hearing Center on 09/29/2021 where I was tested to make sure that the structures in my ears were ok and also tested my hearing. It seemed to be more prevalent in the right ear (Tinnitus). The symptoms continued with the 3rd dosage approximately three weeks after receiving the vaccine and went to see the ENT on 10/18/2021 since the symptoms worsened.
Treatment of COVID-19; Treatment of COVID-19; Rebound Covid 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 11:30 as dose 1, single (Lot number: EL9266) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "DM type 2" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 25Aug2022, outcome "recovered", described as "Rebound Covid 19"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Rebound Covid 19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: Known allergies was reported as none. Follow-up attempts are possible. no further information expected; Sender's Comments: Based on the information in the case, an association between the reported events Drug ineffective and covid 19 and the suspect product BNT162B2cannot be ruled out.
That night patient's arm turned bright red and the lump became hot, inflammed, painful and swollen. He complained he couldn't move or use his arm. He couldn't sleep until about 7am on 2/28/17. The following morning around 10am he spiked a fever of 101.2 and wouldn't eat. Patient had diahrea , a fever and couldn't use his arm due to swelling and pain for a week. He missed a week of school. During that time I returned to the doctor concerned and he said this was normal, however I know it was not. Patient never complained about anything. The doctor brushed me off and told me to keep him home for a few days. He examined patient and agreed his arm was hot and was very swollen. After 13 days the swelling and redness in his arm went away. After about 3 weeks patieint was able to use his arm properly again.
Thursday muscle / body aches with fatigue. Friday rash and my eye. Still having fatigue off and on.
Patient reports headache and chills that started the evening after the vaccine was administered (4/8/21). Headache, fatigue, chills, sore throat, body aches persisted. Patient did not take any medication until 4/12 (Excedrin for migraines), which reportedly made it worse. Patient was advised to go to ER on 4/14/21 in the morning, where a CT scan and blood tests were done with no remarkable findings. Patient was discharged that evening with instructions to hydrate, rest, and take ibuprofen and Tylenol.
Pt had t101, local reaction, had unconsolable cry was not high pitched cry; Seen by local MD who felt pt had normal reaction to DTP; not unusual one local reaction was in rt leg pain swelling, inc warmth;