chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Still feel discomfort in my arm if I pressed on it; Feeling miserable; Inflamed/Stiff neck from inflammation; Inflamed/Stiff neck from inflammation; Could not sleep on that side for the first week; Arm that was so sore; Fatigue; Headache; Optic neuritis flared in my left eye; virus triggered a flare up that knocked her off her feet; Cold; Virus triggered a flare up that knocked me off my feet. I had no sensation of touch or temperature in my left foot; This is a spontaneous report from a contactable other health professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included ongoing relapsing remitting multiple sclerosis/MS diagnosed in 1981 (for 45 years). She has managed her disease with hormones for the past 30 years. Concomitant medications were not reported. She had the most unusual couple of weeks. In Apr2021, three weeks ago she caught a cold rare for her, but she was pretty run down. Cold symptoms did not last in her body, but the virus triggered a flare up that knocked her off her feet. She had no sensation of touch or temperature in left foot and optic neuritis flared in left eye in Apr2021. Worst of all she had that overwhelming fatigue that accompanies a flare up. She woke up Monday (19Apr2021) feeling miserable and inflamed. She was scheduled to get her second Pfizer vaccination at noon. She read that the shot does not make MS conditions worse so she decided to go ahead with her appointment. She had a moderate reaction to her first shot. A headache that lasted a week, a very stiff neck from inflammation, and an arm that was so sore that she could not sleep on that side for the first week in Apr2021. She could still feel discomfort in arm if she pressed on it as she left for her second shot on 19Apr2021. The outcome of event headache, could not sleep was recovered in Apr2021; discomfort in my arm was not recovered; for other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event optic neuritis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once more information regarding event onset and vaccination date is available. Also underlying multiple sclerosis was confounder. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Swelling at injection site; Redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  After receiving 1st dose of Shingrix, the patient experienced swelling and redness at injection site. The customer did not provide lot or expiration date information or report in which arm the vaccine was injected. The reporter did not consent to follow up. This case has been linked with US2020226624, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226624:Same reporter
9 days after the vaccine was given I had swelling, rash and itchiness at the site of the vaccine (mild).   Now have had that for 3 days.  Applied anti-itching cream to site and it helped.  Have not seen my health provider.
Info has been received from an RN concerning a 7 year old male with an allergy to azithromycin (Zithromax) and no pertinent medical history who on 7/31/99 was vaccinated, SC in the left deltoid with a 0.5ml 1st dose of varicella virus vaccine live. Concomitant vaccination on the same day included a 1st dose in the left thigh of MMRII. There was no other concomitant medication. There was no illness at the time of vaccination. On 6/29/05, the pt experienced a rash with some filled vesicles. A questionable unknown exposure was noted. He was treated with Benadryl. Aveeno Bath and calamine lotion. On 7/31/05, the pt had many lesions on his face, scalp and extremities with itching. He was afebrile, alert and not ill. Unspecified medical attention was sought. No diagnostic lab studies were performed. At the time of the report, the pt was recovering. A product quality complaint was not involved. Follow-up info was received from the RN who reported that on 6/29/05, the pt developed breakthrough chickenpox with a rash and itching. The pt was last seen for this on 7/1/05 and subsequently recovered. No further info is expected. 05/16/2008 Information has been received from a registered nurse concerning a 7-year-old male with an allergy to ZITHROMAX and no pertinent medical history who on 31-JUL-1999 at 10:50 AM was vaccinated SC in the left deltoid (also report IM in the left thigh) with a 0.5 ml first dose of VARIVAX (Oka/Merck) (lot # 631067/0447J). Concomitant vaccination on the same day included a first dose in the left thigh of MMR II (MSD). There was no other concomitant medication . There was no illness at the time of vaccination. On 29-JUN-2005, the patient experienced a rash with some filled vesicles. A questionable unknown exposure was noted. He was treated with BENADRYL ELIXIR, AVEENO BATH, and calamine lotion. On 01-JUL-2005, the patient had many lesions on his face, scalp, and extremities with itching. He was afebrile, alert, and not ill. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Follow-up information was received from the registered nurse who reported that on 29-JUN-2005, the patient developed break through chickenpox with a rash and itching. Symptomatic treatment was provided. The patient was last seen for this on 01-JUL-2005 and subsequently recovered. No further information is expected.
Patient received influenza vaccine and started on Amoxicillin 10/24/04. 4 days later diagnosed with erythema multiforme-minor. No treatment needed.
7 month old received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received DTPa-IPV (Kinrix) (batch number z9mz2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included diphtheria toxoid + hepatitis B vaccine + pertussis toxoid + poliomyelitis vaccine + tetanus toxoid (Pediarix).   On 30th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received a dose of Kinrix at the age of 7 months, which led to inappropriate age of vaccination. The patient also received a dose of Pediarix on 14th September 2021, but no adverse events reported for that vaccine. The reporter consented to follow up.
Headache, Arthralgia, Fever, ErythemaMultiform, chills Narrative:  Other Relevant History:
pt recvd vax & devel soreness around ear 11JUN94, nausea & fever; t103; no react @ immun site; no difficulty breathing;
diagnosed with Shingles/suspected vaccination failure; told her she had received the complete series of Shingrix (unknown dates) and was diagnosed with Shingles; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: diagnosed with Shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: told her she had received the complete series of Shingrix (unknown dates) and was diagnosed with Shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date:12 Sep 2023 The reporter stated her friend stated after the completion of primary series of Shingrix approximately one or two months ago she was diagnosed with shingles. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter did not consented to follow up. This was 1 of 2 cases reported by same reporter.; Sender's Comments:  US-GSK-US2023125323:Same reporter, different patient
her ring finger started to turn bluesish purple from the fingernail to the second knuckle; Rash/It is now hard to see the rash spots, if looking closely she can see the red marks under the skin fading; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an age 83 Years received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Right on 04Mar2021 (age at vaccination: 82 Years) as DOSE 1, SINGLE, second dose (BNT162B2, Solution for injection, Batch/Lot Number: ET7534) via an unspecified route of administration in Arm Right on 25Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Medical history included glaucoma from an unknown date and unknown if ongoing, blood cholesterol increased from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced her ring finger started to turn bluesish purple from the fingernail to the second knuckle on an unspecified date, rash/it is now hard to see the rash spots, if looking closely she can see the red marks under the skin fading on Mar2021.Patient had physician office visit for the events when the reporter had received first dose. Therapeutic measures were taken as a result of rash/it is now hard to see the rash spots, if looking closely she can see the red marks under the skin fading was Prednisone reporter was prescribed a lotion instead of prednisone by a dermatologist. The outcome of the event rash erythematous was recovering and the outcome of the event nail discolouration was unknown.  No follow-up attempts are needed. No further information is expected.
Following Pneumovax 23 INJ 25MCG/05 ML injection, sudden fever, R. upper arm swelling and pain; injection site 9 x 7 cm; went to physician next day 11/30/2011 diagnosed with "cellulitis"; prescribed 1 week course of antibiotics.
2 days after receiving the vaccines, the patient was seen with a 5x7cm area of redness about 4cm below the site of the vaccines on the upper arm.  This cellulitis disappeared with a course of erythremyacin.
I felt strong flu symptoms as I was told I could (fever of 101, shivers, nausea, migraine, soreness)  My breastfed baby (6 months old) puked all of her food the day of my second shot.
A few hours after I got the swine flu shot I got a really bad headache which lasted more then a week. Also I was feeling nausea and geting stomach craps. I also had little/no appetite. 11/19/09 Medical records received. OB records. Recent OV 11/16/09 pt. 19wks pregnant, (+)FHR. Normal visit WNL exam. Pt received H1N1 IM vax on 10/26/09. Pt. seen in ER on 10/30/09 w/ c/o N/V x3 days, generalized HA, abd cramping. DX: IUP, vomiting. Diag/Labs: none received. 11/19/2009 ED records for 10/30/2009, patient pregnant presents with c/o's nausea/vomiting, headache, abdominal cramping. Tx: IVF, Zofran
Patient seen due to rash immediately following first COVID vaccine (Pfizer, 6mo to 4 year dose). Pinpoint rash on arms up to shoulders. None on trunk, few on legs. Itchy but he was not scratching at them. No prior reaction to vaccines or other allergies.   Benadryl given.   Normal vitals, normal physical examination. Observed for 1 hour with repeat vitals and examination, again normal.   Adverse reaction added to allergies.
This spontaneous report was received from a nurse practitioner and refers to multiple unspecified patients of unknown age and gender. No information about the patients's medical history, concurrent conditions, drug reactions, allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (of lot # M026306 with an expiration date on 30-APR-2018 or of lot# M024261 with an expiration date on 30-JUL-2018 or of unknown lot # and expiration dates; dose and route of administration were not provided). The details of temperature excursion were unknown. The reporter stated that the temperature went "below range" to an unspecified temperature for an unspecified amount of time. No adverse effects were reported. The temperature was logged by digital data logger and there were no previous excursions. Product quality complaint was not involved. Additional information has been requested.
No adverse event noted  Vaccine given more than 12 hours after vial was punctured.
Patient received 0.5 cc Moderna.  Patient had previously received two doses of Janssen on 5-11-21 and 12-29-21    Patient reported experiencing side effects for two days
pt recvd vax;approx 1/2 later,began screaming cry;refused to nurse or quiet down to sleep;mom PC hlth ctr;apap given;T 100 R;leg swollen from inject site to knee;cold compresses recommended;slept 1/2 hr then woke up screaming;sxs gone by 8p
PRODUCT STORAGE ERROR; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 47 year old male. 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: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 15-AUG-2021 for prophylactic vaccination. Age at time of vaccination 47 years old. No concomitant medications were reported. On 15-AUG-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537356, 20220537444, 20220537507, 20220537532, 20220537548, 20220537683, 20220538149, 20220538238, 20220538297, 20220538316, 20220538411, 20220538425, 20220538480, 20220538627, 20220539045, 20220540324, 20220540420, 20220540435, 20220540536, 20220540642, 20220538890, 20220538292, 20220538693, 20220537341, 20220538146, 20220538210, 20220538347, 20220538379, 20220538428, 20220538437, 20220538666, 20220538758, 20220540816, 20220540765, 20220540688, 20220538573, 20220540570, 20220540853, 20220541085, 20220541180, 20220541401, 20220541506, 20220540814 and 20220540524.
Symptoms on 4/9/2021 Itchinig Rash Red Skin Hot flashes Symptoms on 4/10 Bad swelling of feet pain in ankles and legs 4/11 and 4/12 symptoms include feet and leg pain
1 hrs after receiving Gardasil pt felt weak, dizzy, hyperventilated.  Pt felt dizzy & weak with a headache for 5 days post injection.  Pt went to pediatrician had blood tests-all were WNL.  Pt has fully recovered.  Pt. also complained of joints aching.
Slight Fever, Weak feeling, Body Aches, Head Ache, Chills, Tiredness
Diarrhea for the entire evening and a bad headache for 24 hours straight, regardless of sleep or water intake. Slept a lot for two days after getting the shot.
brachial plexitis - approx 2 days following  injection, development of pain/numbness/tingling down arm to forearm, lt thumb tip numbness
Onset of nausea, dizziness within 30 sec of vaccine administration (HPV) symptoms persisted for full 48hrs per Pt symptoms were severe.
The pt was inadvertently vaccinated and subsequently, the pt had a bad asthma attack. In follow up the pt went to the ER.
This spontaneous report as received from a physician assistant via company representative refers to a couple of patients of unknown age. On an unknown date, a couple of patients were vaccinated with a doses of GARDASIL (doses, routes, lot numbers not reported). On an unknown date, a couple of patients experienced increased severity of pain at the injection site with each subsequent dose of GARDASIL. The outcome of increased severity of pain at the injection site was unknown. A couple of patients sought medical attention via office visit. The relatedness between the adverse event and GARDASIL was not reported. Additional information has been requested.
Patient came in stating he needed to receive a Shingles vaccine and that he had been advised to get vaccinated during a visit to MD. Proir to administration pharmacist reviewed with the patient vaccine regiment and side effects, then administered. On the patient's way out, the pharmacist reiterated that he would want to come back within 2-6 months for the completion of the course (shot #2). It was at this point that the patient stated that he had had at least 1 shingrix vaccine in the past and just figured he was due for another. The pharmacist researched and discovered that the patient had indeed received 2 previous shingles shots on 11/14/19 & 2/9/20. At this point the pharmacist contacted GSK to see if there was any data on 3 vaccines. GSK said that while they do not recommend more than 2 shots, that they had done studies on a 3 shot regimen in immuno-compromised patients. In pertaining to side effects, GSK stated that side effects that were reported were the same as after shot 1 & 2 (pain at injection site, lethargy, fatigue) with no serious or long term effects. This information was communicated to the patient. MD also informed
Patient stated, "When I got home after receiving that shot I was really tired and my back started hurting.  I laid down and slept the majority of the day.  The next day I was just as tired and slept about 12 to 14 hours throughout the day.  Then on the 3rd day I woke up and had blisters in  my mouth and also had a couple on the upper outside lip area.  I was no longer tired but the blisters lasted about 2-3 days.  My arm was also sore for about 1 week.
Headache, joint pain, nausea, leg pain, fever. All about 4 hours and then stopped.
At the time of the shot, I had normal reaction of redness, small hard knot, and soreness.  It stated to fade.  Then about a week later, it started to get red again with a hardness.  It also was itchy.  It was not sore at all.   I have taken Benedryl and Benedryl cream.  It is not itchy now and the hardness is gone.  It is about 2-3 inches in diameter.
An aunt reported that her nephew received Prevnar and DTP on 2/3/01. On 2/24/01, he reportedly experienced a seizure. He experienced another seizure on 3/2/01 and from that date, he experienced seizures every 2 to 3 hours. The pt was hospitalized the next day. He was treated with phenobarbital and transferred to a tertiary care facility. As of 3/5/01, the pt was still hospitalized. The reporter declined to provide additional information.
Hypertensive crisis (BP in October 2020 at a medical facility was 138/84).  Highest BP reading 230/101.  Meds received to lower BP in ER: 10mg amlodipine, oral, 10mg hydralazine IV, 5mg metoprolol IV.   BP upon release from ER 159/85 Follow up with ARNP and cardiologist. Testing revealed no reason for increase in BP, eventually controlled with medication.  Medication has been reduced since initial event due to decreased BP. BP spiked again after vaccine booster in November 2021 and contraction of COVID in January 2022.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 75-year-old female patient who received SHINGRIX. Concurrent medical conditions included blood pressure high, blood cholesterol increased and thyroid disorder. Concomitant products included Levothyroxine. On 25th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On 25th April 2018, the patient experienced chills and fever. On 26th April 2018, the patient experienced exhaustion. On 27th April 2018, the patient experienced welts. The patient was treated with Aspirin. In April 2018, the outcome of the chills was recovered/resolved. On 26th April 2018, the outcome of the fever was recovered/resolved. On 27th April 2018, the outcome of the exhaustion was recovered/resolved. On an unknown date, the outcome of the pain in arm and welts were recovered/resolved. It was unknown if the reporter considered the chills, pain in arms, welts, fever and exhaustion to be related to SHINGRIX. Additional details were provided as follows: Reporter was the patient. At 11:30 hours, the patient received SHINGRIX. At 23:30 hours, the patient experienced chills on the night she received vaccine and resolved within approximately 1.5 hours. The patient experienced fever on the date of vaccination, no temperature was recorded and the fever resolved next morning. Reporter could not provide lot number or expiration date of SHINGRIX. The patient described exhaustion as feeling exhausted while sitting in a chair, and spending most of the day in bed. The patient described welt which was located approximately 6 inches below injection site approximately 3 inches wide and wrapped around the side of the left arm. Welt was hot, swollen, and painful. The patient sought care at urgent care for the welt and was advised to monitor only. Welt resolved approximately 2 days later, no exact date provided. The event sore arm resolved either 30th April 2018 or 1st May 2018, she could not specified.